Study to Evaluate Safety and Efficacy of Blinatumomab in... | NCT02910063

ID	Type	Description	Link
2016-002044-16	EudraCT Number

Status Module

Description Module

Label	Type	Description	Intervention Names
Blinatumomab	Experimental	Blinatumomab is administered as a continuous intravenous infusion (CIVI). A single cycle of blinatumomab is continuous infusion with step dosing of 9 µg/day x 7 days, 28 µg/day x 7 days, and 112 µg/days until the end of the cycle.	Drug: Blinatumomab

Name	Type	Description	Arm Group Labels	Other Names
Blinatumomab	Drug	Blinatumomab monotherapy	Blinatumomab	AMG 103

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR)	Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.	Up to 12 weeks after first dose of blinatumomab
Phase 3: Number of Participants Who Achieved Complete Metabolic Response (CMR)	Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.	Up to 12 weeks after first dose of study treatment

Secondary Outcomes

Measure	Description	Time Frame
Phase 2: Overall Survival (OS)	OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using Kaplan-Meier estimates.	From randomization until the end of study, up to 30 months
Phase 2: Objective Response Rate (ORR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy proven aggressive B-cell Non-Hodgkin Lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), follicular lymphoma Grade 3B, PMBCL, T-cell rich B-cell lymphoma, or DLBCL that represents transformation of indolent non-Hodgkin's Lymphoma (NHL), (including follicular, marginal zone, and lymphoplasmacytoid lymphoma) excluding chronic lymphocytic leukemia or Hodgkin Lymphoma. The following histologies are not eligible:
- Lymphoblastic lymphoma
- Burkitt lymphoma
- Mantle cell lymphoma Any histologies not specifically mentioned must be discussed with medical monitor.
Refractory (no prior CR/CMR) or relapsed (prior CMR) following front line treatment of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. For subjects with refractory disease and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
Biopsy proven confirmation of relapsed disease.
Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy.
Radiographically measurable disease with a demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension
Eastern Cooperative Oncology Group performance status less than or equal to 2
Intention to proceed to high dose chemotherapy (HDT) and autologous hematopoietic stem cell transplant (HSCT)
Laboratory parameters:

Hematology:

Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
Platelets ≥ 75 x 10^9/L

Chemistry:

Creatinine clearance ≥ 50 mL/min
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3X upper limit of normal (ULN)
Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma)

Exclusion Criteria:

CMR following S1 chemotherapy
Treatment within 30 days prior to randomization with another investigational device or drug study (ies).
Prior anti-CD19-directed therapies
Prior HDT with autologous HSCT
Prior allogeneic HSCT
Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Evidence of CNS involvement by NHL
Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti hepatitis C virus positive)
History of malignancy other than B-NHL within the past 3 years with the exception of:
- Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment
- Adequately treated non-melanoma skin cancer or lentigo maligna
- Adequately treated cervical carcinoma in situ
- Adequately treated breast ductal carcinoma in situ
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
Known sensitivity to immunoglobulins or any of the components to be administered during dosing.
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required procedures.
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed, or of childbearing potential unwilling to use an effective method of contraception while receiving, and for an additional 48 hours after the last dose of blinatumomab.

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Duarte	California	91010	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
32546071	Derived	Coyle L, Morley NJ, Rambaldi A, Mason KD, Verhoef G, Furness CL, Zhang A, Jung AS, Cohan D, Franklin JL. Open-Label, phase 2 study of blinatumomab as second salvage therapy in adults with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Leuk Lymphoma. 2020 Sep;61(9):2103-2112. doi: 10.1080/10428194.2020.1759055. Epub 2020 Jun 16.

Label	URL
AmgenTrials clinical trials website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 7, 2019	Dec 18, 2020

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 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR)

Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.

FAS: All participants who received blinatumomab.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 12 weeks after first dose of blinatumomab

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants	OG00041

Title

Denominators

Categories

Title	Measurements
	OG00022.0(10.6 to 37.6)

Primary

Phase 3: Number of Participants Who Achieved Complete Metabolic Response (CMR)

Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.

No data is available for Phase 3. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled.

Posted

Up to 12 weeks after first dose of study treatment

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units

Secondary

Phase 2: Overall Survival (OS)

OS was defined as the time from the date of randomization until death due to any cause.

OS was calculated using Kaplan-Meier estimates.

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

Median

95% Confidence Interval

Months

From randomization until the end of study, up to 30 months

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants	OG000

Secondary

Phase 2: Objective Response Rate (ORR)

ORR is inclusive of all participants who achieved CMR or those who achieved partial metabolic response (PMR), as determined by central radiographic assessment of PET/CT scans using the Lugano Classification.

FAS: All participants who received blinatumomab.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 12 weeks after first dose of blinatumomab

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants	OG000

Secondary

Phase 2: Progression Free Survival (PFS)

PFS was defined as the time from start of treatment with blinatumomab until the date of diagnosis of progression of lymphoma, or date of death, whichever is earliest. PFS was estimated using Kaplan-Meier method.

FAS: All participants who received blinatumomab.

Posted

Median

95% Confidence Interval

Months

From first dose of blinatumomab until the end of study, up to 30 months

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants	OG000

Secondary

Phase 2: Duration of Response (DOR)

DOR was calculated only for participants who achieve a response (CMR or PMR). The duration was calculated from the date a response, CMR or PMR, was first achieved until the earliest date of a disease assessment indicating disease progression or death, whichever occured first. DOR was estimated using Kaplan-Meier method.

Full Analysis Set (FAS): All participants who received blinatumomab.

Posted

Median

95% Confidence Interval

Months

From first dose of blinatumomab up to 12 weeks

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants	OG000

Secondary

Phase 2: Percentage of Participants Who Experienced Successful Mobilization

Successful mobilization rate was defined as the percentage of participants who initiated mobilization while in remission and without any other anti-tumor therapy where the mobilization procedure had an outcome of 'Successful'. Successful mobilization was dictated by institutional standards and defined when the target cell dose was no less than 2 x 10^6 CD34+ cells/kg.

Responder Analysis Set: All participants who had a CMR or PMR per central review during the first 12 weeks after initiation of blinatumomab.

Posted

Number

95% Confidence Interval

Percentage of participants

From first dose of blinatumomab until the end of study, up to 30 months

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants

Secondary

Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)

The percentage of responders per investigator's review (participants who achieved either CMR or PMR during the treatment) who have undergone allogeneic (allo) HSCT or autologous (auto) HSCT while in remission and without any other anti-cancer treatment.

FAS: All participants who received blinatumomab.

Posted

Number

95% Confidence Interval

Percentage of participants

From baseline HSCT until the end of study, up to 30 months

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants

Secondary

Phase 2: Cumulative Incidence Function Estimate of 100-day Mortality After HSCT Presented as Percentage of Participants That Died Not Due to Relapse, With Relapse and Death Due to Relapse as Competing Events

Non-relapse mortality rate at 100 days after HSCT was calculated as the percentage of participants who died not due to relapse. Only participants who achieved a response per investigator's review and underwent autoHSCT are included.

AutoHSCT Analysis Set: All participants who achieved a response and underwent autoHSCT while in remission and without any other anti-cancer treatment.

Posted

Number

95% Confidence Interval

Percentage of participants

100 days after HSCT

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants

Secondary

Phase 2: Blinatumomab Steady State Concentrations (Css)

Pharmacokinetic (PK) parameters were estimated by non compartmental analysis. The Css of blinatumomab was summarized as the observed concentrations collected after at least 24 hours after the start of continuous IV infusion or start of dose step, where appropriate.

PK analysis Set: All subjects who received blinatumomab at each individual dose and had at least one PK sample collected.

Posted

Mean

Standard Deviation

Picograms/millilter (pg/mL)

Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

ID	Title	Description
OG000	Phase 2: Blinatumomab 9 µg/Day	All participants who received blinatumomab 9 µg/day continuous infusion which was administered for 7 days of in Week 1 of Cycle 1 (Cycle 1 was 70 days in length).
OG001	Phase 2: Blinatumomab 28 µg/Day	All participants who received blinatumomab 28 µg/day continuous infusion which was administered for 7 days in Week 2 of Cycle 1 (Cycle 1 was 70 days in length).
OG002	Phase 2: Blinatumomab 112 µg/Day	All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).

Secondary

Phase 2: Blinatumomab Clearance (CL)

Serum blinatumomab CL was calculated as CL=R0/Css,DN; where R0 is the infusion rate (μg/hr) and Css,DN is the dose normalized average Css. For the CL calculation, the Css,DN was normalized to the 112 μg/day dose in which the value of dose in units of μg/hr was used for the infusion rate.

PK analysis Set: All subjects who received any infusion of blinatumomab and had at least one PK sample collected.

Posted

Mean

Standard Deviation

Liter/hour (L/hr)

Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants

Secondary

Phase 2: Half-life of Blinatumomab

Blinatumomab half-life was not reported as the serum blinatumomab concentration data collected for PK assessments did not support its estimation. This is in adherence with the considerations for reporting of PK assessments as detailed in Protocol Section 10.6.

Posted

Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts
Participants	OG000

Secondary

Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

Treatment-emergent adverse events were events with an onset after the administration of the first dose of blinatumomab.

TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE).

Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL).

Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.

Grade 4 Life-threatening consequences; urgent interventions indicated.

Posted

Count of Participants

Participants

From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days

ID	Title	Description
OG000	Phase 2: Blinatumomab	Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.

Units	Counts

Secondary

Phase 3: Objective Response Rate (ORR)

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

Up to 12 weeks after first dose of study treatment

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Progression Free Survival (PFS)

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

From first dose of study treatment until the end of study, up to 30 months

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Duration of Response (DOR)

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

From first dose of study treatment up to 12 weeks

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Percentage of Participants Who Experienced Successful Mobilization

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

From baseline until the end of study, up to 30 months

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

From baseline HSCT until the end of study, up to 30 months

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Percentage of Participants Who Died Within 100 Days After Hematopoietic Stem Cell Transplantation (HSCT) That Was Not Due to Relapse

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

100 days after HSCT

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Change From Baseline in Patient Reported Clinical Outcome Assessments Quality of Life (QOLCOA) Scores

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

Up to 30 days after last dose after study treatment

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

From first dose of study treatment until 30 days after last dose

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Serum Blinatumomab Steady State Concentration (Css)

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

24 hours after first dose of blinatumomab

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Blinatumomab Clearance (CL)

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Secondary

Phase 3: Half-life of Blinatumomab

No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Posted

Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

ID	Title	Description
OG000	Phase 3: Blinatumomab	Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
OG001	Phase 3: Investigator's Choice (IC) Chemotherapy	Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 affected41 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Diffuse large B-cell lymphoma refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0002 affected41 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Hemiparesis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Neurotoxicity	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Confusional state	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0003 affected41 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected41 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0006 affected41 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0005 affected41 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 affected41 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0006 affected41 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 affected41 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0006 affected41 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 affected41 at risk
Asthenia	General disorders	MedDRA 22.1	Systematic Assessment	EG0003 affected41 at risk
Fatigue	General disorders	MedDRA 22.1	Systematic Assessment	EG0004 affected41 at risk
Oedema peripheral	General disorders	MedDRA 22.1	Systematic Assessment	EG0008 affected41 at risk
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0009 affected41 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0004 affected41 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0005 affected41 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0004 affected41 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0009 affected41 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0004 affected41 at risk
Aphasia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 affected41 at risk
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00010 affected41 at risk
Paraesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 affected41 at risk
Tremor	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0009 affected41 at risk
Confusional state	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0004 affected41 at risk
Insomnia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0005 affected41 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 affected41 at risk
Hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0003 affected41 at risk

ID	Term
D016393	Lymphoma, B-Cell
D012008	Recurrence
D007938	Leukemia
D009369	Neoplasms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006402	Hematologic Diseases