Phase 1/2a Dose Escalation Study in Participants With CLL... | NCT01994382 | Trialant
NCT01994382
Sponsor
Alexion Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Apr 5, 2022Actual
Enrollment
260Actual
Phase
Phase 1Phase 2
Conditions
Follicular Lymphoma (FL/Indolent NHL)
Aggressive NHL (a NHL)
Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
T-cell Lymphoma (PTCL and CTCL)
B-cell Non Hodgkin Lymphoma (NHL)
Interventions
Cerdulatinib
Rituximab
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01994382
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
13-601
Secondary IDs
Not provided
Brief Title
Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL
Official Title
A Phase 1/2a Open-Label, Multi-Dose, Multi-Center Escalation and Exploratory Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or B-Cell or T-Cell Non-Hodgkin Lymphoma (NHL)
Acronym
Not provided
Organization
Alexion Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Apr 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT04757259No longer available
Start Date
Aug 30, 2013Actual
Primary Completion Date
Dec 15, 2020Actual
Completion Date
Dec 15, 2020Actual
First Submitted Date
Nov 8, 2013
First Submission Date that Met QC Criteria
Nov 19, 2013
First Posted Date
Nov 25, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 15, 2022
Results First Submitted that Met QC Criteria
Apr 1, 2022
Results First Posted Date
Apr 5, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 13, 2021
Certification/Extension First Submitted that Passed QC Review
Dec 13, 2021
Certification/Extension First Posted Date
Dec 16, 2021Actual
Last Update Submitted Date
Apr 1, 2022
Last Update Posted Date
Apr 5, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alexion Pharmaceuticals, Inc.INDUSTRY
Collaborators
Name
Class
Portola Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.
Detailed Description
This is an open-label, Phase 1/2a, multi-dose, multi-center trial of orally administered cerdulatinib assessing safety, tolerability, and pharmacokinetic (PK) parameters conducted in 2 phases:
Phase 1: Dose-escalation portion, during which participants will be enrolled to receive a single-agent cerdulatinib at their assigned dose level starting at 15 milligrams (mg) once daily (QD), administered in increasing doses until the maximum tolerated dose (MTD)/maximum administered dose (MAD) is identified.
Phase 2a: Consisting of planned cohorts based on cancer type. The participants will receive single agent cerdulatinib at a starting dose of 35, 30, or 20 mg twice daily (BID) for 28-day cycles except for one of the cohorts, the participants will receive cerdulatinib plus intravenous (IV) rituximab at 375 mg/square meter (m^2) for 28-day cycles.
Conditions Module
Conditions
Follicular Lymphoma (FL/Indolent NHL)
Aggressive NHL (a NHL)
Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
T-cell Lymphoma (PTCL and CTCL)
B-cell Non Hodgkin Lymphoma (NHL)
Keywords
Leukemia
Lymphocytic
Chronic
B Cell
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
260Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1 Cerdulatinib
Experimental
During Phase 1, participants will receive oral cerdulatinib on Day 1 and then starting on Day 4 at doses of 15 mg up to 100 mg QD or oral cerdulatinib at doses of 15 mg up to 45 mg BID in 28-day cycles (except Cohort 1 will have a 21-day cycle starting on Day 1) for up to 10 cycles.
Drug: Cerdulatinib
Phase 2a Cerdulatinib
Experimental
During Phase 2a, participants in cohorts based on cancer type will receive oral cerdulatinib at starting doses of 35, 30, or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib can be reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
Drug: Cerdulatinib
Phase 2a Cerdulatinib plus Rituximab
Experimental
During Phase 2a, participants in this cohort will receive oral cerdulatinib at their applicable dose and an IV injection of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
Drug: Cerdulatinib
Biological: Rituximab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cerdulatinib
Drug
Oral capsule
Phase 1 Cerdulatinib
Phase 2a Cerdulatinib
Phase 2a Cerdulatinib plus Rituximab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT)
DLT was defined as any of the following toxicities, possibly or probably related to cerdulatinib, and clinically significant (in the judgement of Investigator): -Febrile neutropenia (absolute neutrophil count <1000/microliter [μL] and temperature ≥38.5°Celcius). -Grade 4 neutropenia for >5 days. -Grade 4 thrombocytopenia with or without bleeding. -Grade 3 thrombocytopenia with bleeding. -Grade 4 anemia, unexplained by underlying disease. -Grade 3 or greater nausea, vomiting, or diarrhea if persistent despite optimal antiemetic or anti-diarrheal therapy. -Grade 3 or greater increase in transaminases lasting >5 days. -Grade 3 or greater fatigue persisting >7 days in absence of any other underlying cause. -Any other Grade 3 or greater non-hematologic toxicity (except fatigue as noted above) considered clinically significant by Investigator. -Toxicity of any grade resulting in dose delay of >7 days. -Toxicity resulting in study drug discontinuation prior to completion of Cycle 1.
Baseline up to Day 28 of Cycle 1 (cycle = 21 days or 28 days)
Phase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator
CR included: -Via a positron emission tomography (PET)/computed tomography (CT) scan, score of 1 (no uptake above background), 2 (uptake of <mediastinum), or 3 (uptake of >mediastinum but <liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to <1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative.
PR included: -Via a PET/CT scan, score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, >50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites.
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator
CR included: -Via a PET/CT scan, score of 1 (no uptake above background), 2 (uptake of <mediastinum), or 3 (uptake of >mediastinum but <liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of FDG-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to <1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative.
PR included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, >50% decrease in the sum of the product of perpendicular diameters for multiple lesion of up to 6 target measurable nodes and extranodal sites.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Phase 1 Inclusion
• Participant at least 18 years of age with histologically confirmed CLL/SLL or B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], FL, mantle cell lymphoma [MCL], marginal zone lymphoma [MZL], lymphoplasmacytic lymphoma).
Phase 2a Inclusion
Histological evidence: FL Grade 1-3A, with relapsed or refractory disease; aggressive NHL (aNHL), defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, peripheral T-cell lymphoma (PTCL), or cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides [MF]/Sézary Syndrome [SS]) with relapsed or refractory disease
Received B-cell receptor (BCR) and/or BCL2 inhibitors and were intolerant or had relapsed/refractory disease afterwards
Prior treatment for lymphoid malignancy for progressive /refractory disease
≥1 prior regimen (minimum 2 cycles) with antibody conjugate/cytotoxic chemotherapy.
Measurable disease defined as: ≥1 lesion that measures ≥1.5 centimeter (cm) single dimension via computed tomography (CT), CT/positive-emission tomography (PET) with nodal or mass lesions; quantifiable circulating tumor cells; and for CTCL: Modified Severity Weighted Assessment Tool (mSWAT) >0
Ability to provide diagnostic reports
General Inclusion
Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1
Hematologic absolute neutrophil count (ANC) >1000/microliter (uL) and platelet >75,000/uL
Creatinine levels as specified by Investigator
Bilirubin <2.0 mg/deciliter [dL] (if Gilberts then <2.5 mg/dL) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2.5*ULN
Exclusion Criteria:
Richter's syndrome, Burkitt's lymphoma, or Burkitt-like Lymphoma (transformed DLBCL from follicular NHL are eligible)
Prior transplant with stem cell infusion within 90 days of Day 1 or active graft-versus-host treatment within 8 weeks of Day 1
Prior therapy with Spleen Tyrosine Kinase (SYK) inhibitors
Chronic treatment with strong CYP3A4 inhibitor/inducer
Known lymphomatous involvement of the central nervous system (CNS)
Persistent, unresolved National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 ≥Grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy).
Prior monoclonal antibody (including alemtuzumab), radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks of Day 1
For CTCL: (total skin electron beam therapy [TSEBT]) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. Stable topical regimen for ≥4 weeks prior to Day 1 allowed.
Known carrier or infection for human immunodeficiency virus (HIV)/hepatitis B or C. If hepatitis C virus (HCV) antibody (ab)+, must be polymerase chain reaction (PCR)- to be eligible. If hepatitis B virus (HBV) ab+, must be hepatitis B surface antigen (HBsAg)- or undetectable HBV deoxyribonucleic acid (DNA) to be eligible.
Active infection requiring systemic treatment,
Significant gastrointestinal (GI) disease, previous major gastric/bowel surgery, difficulty swallowing, or malabsorption syndrome
Major surgery within 4 weeks
Previous malignancies within 2 years unless relapse risk is small (<5%).
Current use of systemic steroids >20 mg QD prednisone (or equivalent)
Breastfeeding or pregnant (intention to become) females or participation in other clinical trials
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Portola Study Director
Portola Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Huntsville
Alabama
35805
United States
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Paul A. Hamlin, Manish R. Patel, Don Stevens, Brian T. Hess, Javier Munoz, Tatyana A. Feldman, Sonali M. Smith, Greg P. Coffey, Muhtarjan Osman, Jaymes S Holland, Cristina B Guzman, Stephen D. Smith; Phase 2a Study of the Dual SYK/JAK Inhibitor Cerdulatinib (ALXN2075) As Monotherapy or in Combination with Rituximab in Patients with Relapsed/Refractory Follicular Lymphoma. Blood 2021; 138 (Supplement 1): 2423. doi: https://doi.org/10.1182/blood-2021-148313
Coffey GP, Feng J, Betz A, Pandey A, Birrell M, Leeds JM, Der K, Kadri S, Lu P, Segal J, Wang YL, Michelson G, Curnutte JT, Conley PB. Cerdulatinib Pharmacodynamics and Relationships to Tumor Response Following Oral Dosing in Patients with Relapsed/Refractory B-cell Malignancies. Clin Cancer Res. 2019 Feb 15;25(4):1174-1184. doi: 10.1158/1078-0432.CCR-18-1047. Epub 2018 Oct 17.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Phase 1: dose-escalation portion of study, participants received doses of cerdulatinib at assigned regimen. Phase 2a: participants were enrolled into cohorts based on cancer type and received single agent cerdulatinib except for 1 cohort, participants received cerdulatinib+rituximab. Three participants in Phase 1 rolled over to Phase 2; their data are included in respective arms in both phases. Therefore, the data are included twice in the Totals for Participant Flow & Baseline Characteristics.
Recruitment Details
This was an open-label study with 2 phases.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: Cerdulatinib 15 Milligrams (mg) Once Daily (QD)
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
FG001
Phase 1: Cerdulatinib 30 mg QD
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 14, 2019
Apr 1, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
PRT062070
ALXN2075
Rituximab
Biological
IV infusion
Phase 2a Cerdulatinib plus Rituximab
Rituxan®
Truxima®
Rixathon®
Ruxience®
MabThera®
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])
Phase 1: Number of Participants Achieving Clinical Benefit
Clinical benefit was defined as achieving stable disease (SD) or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, <50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])
Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)
An AE is any untoward medical occurrence, which may or may not have a causal relationship to the study drug, including: unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug; any newly occurring event or exacerbation of previous condition (for example, increase in severity or frequency) since the administration of study drug; recurrence of an intermittent medical condition not present at baseline; any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug; and AEs related to a study intervention. An SAE is an AE that is fatal, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of Cerdulatinib
Phase 2a: Median Time to Progression-Free Survival (PFS)
PFS=(first documentation of disease progression [DP] or death [whichever occurred first]-study drug first dose date+1)/30.4375 in months. PFS right censored for 1 of these conditions: 1) no baseline disease assessments; 2) starting new anticancer therapy before documented DP/death; 3) DP/death immediately after >6 months since last disease assessment (or >12 months if after last cycle); & alive without documented DP. 95% confidence interval estimated using Brookmeyer method. DP included: -Via a PET/CT scan, score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with uptake increase in intensity, new FDG-avid foci, & no nonmeasured lesions. -Via CT, abnormal individual node/lesion with significant LDi or shortest axis perpendicular to LDi increase; prior splenomegaly, >50% splenic length increase; if no prior splenomegaly, ≥2 cm splenic length increase; new or recurrent splenomegaly; new/clear progression of preexisting nonmeasured lesions.
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])
Phase 2a: Number of Participants Achieving Clinical Benefit
Clinical benefit was defined as achieving SD or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, <50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])
Phase 2a: Number of Participants Achieving Dominant Mass Response (DMR)
DMR was defined as achieving a ≥50% decrease from baseline in the SPD of the target nodal and extranodal lesions. SPD at a visit was considered missing if any target lesion was not evaluated.
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])
Gilbert
Arizona
85234
United States
Los Angeles
California
90095
United States
Palo Alto
California
94304
United States
Washington D.C.
District of Columbia
20007
United States
Gainesville
Florida
32608
United States
Sarasota
Florida
34232
United States
Lawrenceville
Georgia
30046
United States
Chicago
Illinois
60637
United States
Louisville
Kentucky
40207
United States
Baltimore
Maryland
21229
United States
Ann Arbor
Michigan
48109
United States
Hattiesburg
Mississippi
39402
United States
Hackensack
New Jersey
07601
United States
Morristown
New Jersey
07960
United States
New York
New York
10021
United States
Philadelphia
Pennsylvania
19104
United States
Charleston
South Carolina
29412
United States
Arlington
Texas
76012
United States
Lubbock
Texas
79410
United States
Richmond
Virginia
23226
United States
Seattle
Washington
98109
United States
Milwaukee
Wisconsin
53226
United States
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
FG002
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
FG003
Phase 1: Cerdulatinib 15 mg Twice Daily (BID)
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
FG004
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
FG005
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
FG006
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
FG007
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
FG008
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
FG009
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
FG010
Phase 2a: Cerdulatinib (FL Cohort)
Participants with follicular lymphoma (FL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
FG011
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with marginal zone lymphoma/Waldenström's macroglobulinemia (MZL/WM) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
FG012
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received intravenous (IV) injections of rituximab 375 milligrams (mg)/square meter (m^2) on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
FG013
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aggressive non-Hodgkin lymphoma (aNHL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
FG014
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with chronic lymphocytic leukemia/small cell lymphocytic lymphoma (CLL/SLL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
FG015
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with peripheral T-cell lymphoma (PTCL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
FG016
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with cutaneous T-cell lymphoma (CTCL) received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
FG0003 subjects
FG0016 subjects
FG0027 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0064 subjects
FG0076 subjects
FG0083 subjects
FG0095 subjects
FG01042 subjects
FG01112 subjects
FG01226 subjects
FG0136 subjects
FG01428 subjects
FG01565 subjects
FG01641 subjects
Received at Least 1 Dose of Study Drug
Safety Population
FG0003 subjects
FG0016 subjects
FG0027 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0064 subjects
FG0076 subjects
FG0083 subjects
FG0095 subjects
FG01042 subjects
FG01112 subjects
FG01226 subjects
FG0136 subjects
FG01428 subjects
FG01565 subjects
FG01641 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0027 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0064 subjects
FG0076 subjects
FG0083 subjects
FG0095 subjects
FG01042 subjects
FG01112 subjects
FG01226 subjects
FG0136 subjects
FG01428 subjects
FG01565 subjects
FG01641 subjects
Type
Comment
Reasons
Informed consent withdrawn
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Progressive disease
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG0033 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Other than specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participants rolled over into expanded access program (NCT04757259)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Protocol violation/noncompliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Rolled over to Phase 2a
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
The Safety Analysis Population included participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: Cerdulatinib 15 mg QD
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
BG001
Phase 1: Cerdulatinib 30 mg QD
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
BG002
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
BG003
Phase 1: Cerdulatinib 15 mg BID
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
BG004
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
BG005
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
BG006
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
BG007
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
BG008
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
BG009
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
BG010
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
BG011
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
BG012
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
BG013
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
BG014
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
BG015
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
BG016
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG0027
BG0033
BG0043
BG0053
BG0064
BG0076
BG0083
BG0095
BG01042
BG01112
BG01226
BG0136
BG01428
BG01565
BG01641
BG017263
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT)
DLT was defined as any of the following toxicities, possibly or probably related to cerdulatinib, and clinically significant (in the judgement of Investigator): -Febrile neutropenia (absolute neutrophil count <1000/microliter [μL] and temperature ≥38.5°Celcius). -Grade 4 neutropenia for >5 days. -Grade 4 thrombocytopenia with or without bleeding. -Grade 3 thrombocytopenia with bleeding. -Grade 4 anemia, unexplained by underlying disease. -Grade 3 or greater nausea, vomiting, or diarrhea if persistent despite optimal antiemetic or anti-diarrheal therapy. -Grade 3 or greater increase in transaminases lasting >5 days. -Grade 3 or greater fatigue persisting >7 days in absence of any other underlying cause. -Any other Grade 3 or greater non-hematologic toxicity (except fatigue as noted above) considered clinically significant by Investigator. -Toxicity of any grade resulting in dose delay of >7 days. -Toxicity resulting in study drug discontinuation prior to completion of Cycle 1.
The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure. Evaluable participants for this Outcome Measure must have received 80% of doses in Cycle 1 or withdrawn from study drug due to drug-related toxicity.
Posted
Count of Participants
Participants
Baseline up to Day 28 of Cycle 1 (cycle = 21 days or 28 days)
ID
Title
Description
OG000
Phase 1: Cerdulatinib 15 mg QD
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
OG001
Phase 1: Cerdulatinib 30 mg QD
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG002
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG003
Phase 1: Cerdulatinib 15 mg BID
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG004
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG005
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG006
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
Units
Counts
Participants
OG0003
OG0016
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator
CR included: -Via a positron emission tomography (PET)/computed tomography (CT) scan, score of 1 (no uptake above background), 2 (uptake of <mediastinum), or 3 (uptake of >mediastinum but <liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to <1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative.
PR included: -Via a PET/CT scan, score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, >50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites.
The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])
ID
Title
Description
OG000
Phase 2a: Cerdulatinib (FL Cohort) With ≤3 Prior Regimen
Secondary
Phase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator
CR included: -Via a PET/CT scan, score of 1 (no uptake above background), 2 (uptake of <mediastinum), or 3 (uptake of >mediastinum but <liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of FDG-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to <1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative.
PR included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, >50% decrease in the sum of the product of perpendicular diameters for multiple lesion of up to 6 target measurable nodes and extranodal sites.
The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure.
Posted
Count of Participants
Participants
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])
ID
Title
Description
OG000
Phase 1: Cerdulatinib 15 mg QD
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
OG001
Phase 1: Cerdulatinib 30 mg QD
Secondary
Phase 1: Number of Participants Achieving Clinical Benefit
Clinical benefit was defined as achieving stable disease (SD) or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, <50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.
The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure.
Posted
Count of Participants
Participants
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])
ID
Title
Description
OG000
Phase 1: Cerdulatinib 15 mg QD
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
OG001
Phase 1: Cerdulatinib 30 mg QD
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
Secondary
Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)
An AE is any untoward medical occurrence, which may or may not have a causal relationship to the study drug, including: unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug; any newly occurring event or exacerbation of previous condition (for example, increase in severity or frequency) since the administration of study drug; recurrence of an intermittent medical condition not present at baseline; any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug; and AEs related to a study intervention. An SAE is an AE that is fatal, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
The Safety Analysis Population included participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
ID
Title
Description
OG000
Phase 1: Cerdulatinib 15 mg QD
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
OG001
Phase 1: Cerdulatinib 30 mg QD
Secondary
Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of Cerdulatinib
The Pharmacokinetic Analysis Population consisted of all participants who received the requisite treatments and have data at the required timepoints. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specified timepoints.
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
OG001
Phase 1: Cerdulatinib 30 mg QD
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG002
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
Secondary
Phase 2a: Median Time to Progression-Free Survival (PFS)
PFS=(first documentation of disease progression [DP] or death [whichever occurred first]-study drug first dose date+1)/30.4375 in months. PFS right censored for 1 of these conditions: 1) no baseline disease assessments; 2) starting new anticancer therapy before documented DP/death; 3) DP/death immediately after >6 months since last disease assessment (or >12 months if after last cycle); & alive without documented DP. 95% confidence interval estimated using Brookmeyer method. DP included: -Via a PET/CT scan, score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with uptake increase in intensity, new FDG-avid foci, & no nonmeasured lesions. -Via CT, abnormal individual node/lesion with significant LDi or shortest axis perpendicular to LDi increase; prior splenomegaly, >50% splenic length increase; if no prior splenomegaly, ≥2 cm splenic length increase; new or recurrent splenomegaly; new/clear progression of preexisting nonmeasured lesions.
The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
months
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])
ID
Title
Description
OG000
Phase 2a: Cerdulatinib (FL Cohort) With ≤3 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
Secondary
Phase 2a: Number of Participants Achieving Clinical Benefit
Clinical benefit was defined as achieving SD or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately >liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, <50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.
The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])
ID
Title
Description
OG000
Phase 2a: Cerdulatinib (FL Cohort) With ≤3 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
Secondary
Phase 2a: Number of Participants Achieving Dominant Mass Response (DMR)
DMR was defined as achieving a ≥50% decrease from baseline in the SPD of the target nodal and extranodal lesions. SPD at a visit was considered missing if any target lesion was not evaluated.
The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])
ID
Title
Description
OG000
Phase 2a: Cerdulatinib (FL Cohort) With ≤3 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
OG001
Phase 2a: Cerdulatinib (FL Cohort) With ≥4 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
Time Frame
Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])
Description
The Safety Analysis Population included participants who received at least 1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1: Cerdulatinib 15 mg QD
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
0
3
0
3
3
3
EG001
Phase 1: Cerdulatinib 30 mg QD
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
0
6
2
6
6
6
EG002
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
0
7
4
7
7
7
EG003
Phase 1: Cerdulatinib 15 mg BID
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
0
3
0
3
3
3
EG004
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
1
3
1
3
3
3
EG005
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
0
3
0
3
3
3
EG006
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
0
4
2
4
4
4
EG007
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
0
6
2
6
6
6
EG008
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
1
3
2
3
3
3
EG009
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
1
5
3
5
5
5
EG010
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
0
42
22
42
42
42
EG011
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
0
12
2
12
12
12
EG012
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
0
26
7
26
26
26
EG013
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
0
6
3
6
6
6
EG014
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
0
28
17
28
28
28
EG015
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
1
65
42
65
65
65
EG016
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
0
41
21
41
41
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected3 at risk
EG0091 affected5 at risk
EG0102 affected42 at risk
EG0110 affected12 at risk
EG0121 affected26 at risk
EG0130 affected6 at risk
EG0142 affected28 at risk
EG0153 affected65 at risk
EG0162 affected41 at risk
Diverticulum
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Lung infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Disease progression
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Non-Hodgkin lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Nocardiosis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Skin infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Epstein-Barr virus infection reactivation
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Septic shock
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Brain abscess
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Corynebacterium sepsis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cytomegalovirus gastritis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Device related infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Localised infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Scedosporium infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
West Nile viral infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Wound infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Fistula of small intestine
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Uvulitis
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Adenocarcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Anal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Death
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Mucosal inflammation
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Sudden death
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Swelling face
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Methaemoglobinaemia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Embolism
Vascular disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Acute motor axonal neuropathy
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA Version 16.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Platelet count decreased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Amylase increased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Graft versus host disease
Immune system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Drug reaction with eosinophilia and systemic symptoms
Skin and subcutaneous tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0023 affected7 at risk
EG0032 affected3 at risk
EG0042 affected3 at risk
EG0050 affected3 at risk
EG0062 affected4 at risk
EG0074 affected6 at risk
EG0083 affected3 at risk
EG0095 affected5 at risk
EG01023 affected42 at risk
EG0115 affected12 at risk
EG01221 affected26 at risk
EG0132 affected6 at risk
EG01420 affected28 at risk
EG01527 affected65 at risk
EG01620 affected41 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0023 affected7 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected6 at risk
EG0022 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0022 affected7 at risk
EG003
Fatigue
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0026 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0024 affected7 at risk
EG003
Pain
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0023 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0023 affected7 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected6 at risk
EG0022 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Weight Decreased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0022 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0020 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 16.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chills
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lipase Increased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Amylase Increased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Skin Infection
Infections and infestations
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 16.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Key limitations of the study included that it was originally a single-arm, short-term study; disease progression was included as an AE; inadequate follow-up for death or progression; a lack of use of antimicrobial prophylaxis; and no uniform gastrointestinal toxicity management algorithm. These limitations impacted dose reduction and discontinuations due to treatment emergent AEs. In addition, monitoring issues due to the COVID-19 pandemic also factored into data collection and verification.
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG008
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG009
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
3
OG0043
OG0053
OG0064
OG0076
OG0083
OG0095
0
OG0040
OG0050
OG0060
OG0070
OG0081
OG0092
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
OG001
Phase 2a: Cerdulatinib (FL Cohort) With ≥4 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
OG002
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≤3 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
OG003
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≥4 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
OG004
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
OG005
Phase 2a: Cerdulatinib (PTCL Cohort) With NOS
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL not otherwise specified (NOS).
OG006
Phase 2a: Cerdulatinib (PTCL Cohort) With Other
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of other PTCL pathology subgroups not included in AITL/TFH or NOS subgroups.
Units
Counts
Participants
OG00024
OG00110
OG00216
OG00310
OG00427
OG0059
OG00622
Title
Denominators
Categories
Title
Measurements
OG00012
OG0016
OG00215
OG0035
OG00414
OG0050
OG0067
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG002
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG003
Phase 1: Cerdulatinib 15 mg BID
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG004
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG005
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG006
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG007
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG008
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG009
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
Units
Counts
Participants
OG0003
OG0016
OG0027
OG0033
OG0043
OG0053
OG0064
OG0076
OG0083
OG0095
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0092
OG002
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG003
Phase 1: Cerdulatinib 15 mg BID
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG004
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG005
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG006
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG007
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG008
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG009
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
Units
Counts
Participants
OG0003
OG0016
OG0027
OG0033
OG0043
OG0053
OG0064
OG0076
OG0083
OG0095
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0024
OG0031
OG0041
OG0050
OG0062
OG0072
OG0081
OG0091
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG002
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG003
Phase 1: Cerdulatinib 15 mg BID
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG004
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG005
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG006
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG007
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG008
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG009
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG010
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
OG011
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
OG012
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
OG013
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
OG014
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
OG015
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
OG016
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable, at the discretion of the Investigator based upon clinical judgment and with Sponsor Medical Monitor approval.
Units
Counts
Participants
OG0003
OG0016
OG0027
OG0033
OG0043
OG0053
OG0064
OG0076
OG0083
OG0095
OG01042
OG01112
OG01226
OG0136
OG01428
OG01565
OG01641
Title
Denominators
Categories
AE
Title
Measurements
OG0003
OG0016
OG0027
OG0033
OG0043
OG0053
OG0064
OG0076
OG0083
OG0095
OG01042
OG01112
OG01226
OG0136
OG01428
OG01565
OG01641
SAE
Title
Measurements
OG0000
OG0012
OG0024
OG003
OG003
Phase 1: Cerdulatinib 15 mg BID
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG004
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG005
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
OG006
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG007
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG008
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
OG009
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
Units
Counts
Participants
OG0003
OG0016
OG0027
OG0033
OG0043
OG0053
OG0064
OG0075
OG0083
OG0095
Title
Denominators
Categories
Day 1 of Cycle 1
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG000709.6± 37.823
OG0011040± 347.34
OG0021826± 713.67
OG003
Day 1 of Cycle 2
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
OG001
Phase 2a: Cerdulatinib (FL Cohort) With ≥4 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
OG002
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≤3 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
OG003
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≥4 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
OG004
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
OG005
Phase 2a: Cerdulatinib (PTCL Cohort) With NOS
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL not otherwise specified (NOS).
OG006
Phase 2a: Cerdulatinib (PTCL Cohort) With Other
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of other PTCL pathology subgroups not included in AITL/TFH or NOS subgroups.
Units
Counts
Participants
OG00024
OG00110
OG00216
OG00310
OG00427
OG0059
OG00622
Title
Denominators
Categories
Title
Measurements
OG00012.68(4.53 to NA)NA=not applicable. Due to several participants who were censored (see conditions detailed above) the upper limit could not be estimated.
OG0013.61(1.28 to NA)Due to several participants who were censored (see conditions detailed above) the upper limit could not be estimated.
OG00218.33(10.74 to NA)Due to several participants who were censored (see conditions detailed above) the upper limit could not be estimated.
OG003NA(3.58 to NA)Due to several participants who were censored (see conditions detailed above) the median and the upper limit could not be estimated.
OG0044.57(1.71 to 9.99)
OG0051.18(0.26 to 3.58)
OG0063.45(2.07 to 5.62)
OG001
Phase 2a: Cerdulatinib (FL Cohort) With ≥4 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
OG002
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≤3 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
OG003
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≥4 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
OG004
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
OG005
Phase 2a: Cerdulatinib (PTCL Cohort) With NOS
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL not otherwise specified (NOS).
OG006
Phase 2a: Cerdulatinib (PTCL Cohort) With Other
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of other PTCL pathology subgroups not included in AITL/TFH or NOS subgroups.
Units
Counts
Participants
OG00024
OG00110
OG00216
OG00310
OG00427
OG0059
OG00622
Title
Denominators
Categories
Title
Measurements
OG00019
OG0018
OG00216
OG00310
OG00417
OG0052
OG00616
OG002
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≤3 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≤3 times before study start.
OG003
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort) With ≥4 Prior Regimen
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. Participants also received IV injections of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10. Participants in this cohort received prior treatment regimen of ≥4 times before study start.
OG004
Phase 2a: Cerdulatinib (PTCL Cohort) With AITL/TFH
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL angioimmunoblastic T-cell lymphoma (AITCL/AITL) and PTCL with T-follicular helper phenotype (TFH).
OG005
Phase 2a: Cerdulatinib (PTCL Cohort) With NOS
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of PTCL not otherwise specified (NOS).
OG006
Phase 2a: Cerdulatinib (PTCL Cohort) With Other
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable. This cohort included participants with cancer type of other PTCL pathology subgroups not included in AITL/TFH or NOS subgroups.