Dasatinib for Modulating Immune System After Autologous S... | NCT01609816 | Trialant
NCT01609816
Sponsor
Barbara Ann Karmanos Cancer Institute
Status
Terminated
Last Update Posted
Mar 16, 2020Actual
Enrollment
8Actual
Phase
Phase 1
Conditions
Non-Hodgkin's Lymphoma
Multiple
Mycosis Fungoides
Hodgkin's Lymphoma
Multiple Myeloma
Interventions
Dasatinib
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01609816
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2011-203
Secondary IDs
Not provided
Brief Title
Dasatinib for Modulating Immune System After Autologous Stem Cell Transplants for Multiple Myeloma, Non-Hodgkin, or Hodgkin Lymphoma
Official Title
Phase I Study of Dasatinib in Recipients of Autologous Stem Cell Transplantation for Hematologic Malignancies.
Acronym
Not provided
Organization
Barbara Ann Karmanos Cancer InstituteOTHER
Status Module
Record Verification Date
Mar 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Low accrual. No Analyses were performed
Expanded Access Info
No
Start Date
Feb 12, 2015Actual
Primary Completion Date
Oct 9, 2018Actual
Completion Date
Oct 9, 2018Actual
First Submitted Date
May 30, 2012
First Submission Date that Met QC Criteria
May 30, 2012
First Posted Date
Jun 1, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 12, 2020
Last Update Posted Date
Mar 16, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Abhinav Deol, Principal Investigator, Barbara Ann Karmanos Cancer InstitutePrincipal Investigator
Lead Sponsor
Barbara Ann Karmanos Cancer InstituteOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 uses a drug called dasatinib to produce an anti-cancer effect called large granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as natural killer cells that remove cancer cells. Researchers think that dasatinib may cause large granular lymphocyte expansion to happen in patients who have received a blood stem cell transplant (SCT) between 3 to 15 months after the blood SCT. In this research study, researchers want to find how well dasatinib can be tolerated, the best dose to take of dasatinib and to estimate how often large granular lymphocytic cellular expansion happens at the best dose of dasatinib.
Detailed Description
This is a phase I, dose-escalation study.
Conditions Module
Conditions
Non-Hodgkin's Lymphoma
Multiple
Mycosis Fungoides
Hodgkin's Lymphoma
Multiple Myeloma
Keywords
adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult lymphoblastic lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II mantle cell lymphoma
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
8Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dasatinib
Experimental
This is a phase 1 dose escalation study, using a standard 3+3 design. Dasatinib is administered orally once daily in the outpatient setting. The starting dose of dasatinib is 20 mg daily. The increment of dose escalation is 20 mg per dose level. Thus, there will be 5 dose levels (20 mg, 40 mg, 60 mg, 80 mg and 100 mg, respectively) with 3 patients in each cohort. Patients will continue on dasatinib for 6 months
Drug: Dasatinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dasatinib
Drug
Patients receive dasatinib PO every day (QD) for 6 months.
Dasatinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4
2 months
Maximum tolerated dose (MTD)graded according to the NCI CTCAE version 4
Defined as highest dose at which no more than one of dose limiting toxicity (DLT) is observed (among the first 6 patients treated and evaluable for toxicity for the purpose of cohort dose escalation decisions).
2 months
Secondary Outcomes
Measure
Description
Time Frame
Incidence of large granular lymphocytes (LGL) lymphocytosis
95% confidence intervals estimated.
6 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Recipients of first ASCT for the treatment of hematologic malignancies (multiple myeloma, Hodgkin's and non Hodgkin's lymphoma)
Patients must be between 100 to 180 days after ASCT
Dasatinib use prior to ASCT is allowed
Performance status >= 60%
Presence of LGL clone prior to enrollment will not be an exclusion criterion if the LGL clone is < 25% of T cell population
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
Hepatic enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) =< 2.5 times the institutional ULN
Serum creatinine < 1.5 times the institutional ULN
Hemoglobin >= 8 g/dL
Absolute neutrophil counts >= 1,500 cells per uL
Platelets >= 100,000 per uL
Patient should be able to provide signed written informed consent; before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel; written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
Patient should be able to take oral medication (dasatinib must be swallowed whole)
Exclusion Criteria:
Patients who have evidence of disease progression before day 100 after ASCT
Sex and reproductive status:
Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug
Women who are pregnant or breastfeeding
Women with a positive pregnancy test
Sexually active fertile men not using effective birth control if their partners are WOCBP
Medical history and concurrent diseases:
No malignancy (other than the one treated in this study) which required radiotherapy or systemic treatment within the past 5 years
Concurrent medical condition which may increase the risk of toxicity, including:
Pleural or pericardial effusion of any grade at the time of screening for study
Cardiac symptoms; any of the following should be considered for exclusion:
History of significant bleeding disorder unrelated to cancer, including:
Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)* Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
Ongoing or recent (=< 3 months) significant gastrointestinal bleeding
Any previous history of >= grade 3 toxicity to dasatinib
Prohibited treatments and or therapies
Category I drugs that are generally accepted to have a risk of causing torsades de pointes including: (patients must discontinue drug 7 days prior to starting dasatinib):