B-Cell Non Hodgkin Lymphoma
Conditions
Keywords
Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma, Blinatumomab, Leukemia, Standard of Care, SOC, Cancer, Chemotherapy
Brief summary
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy. In March 2019, decision made to not proceed with phase 3.
Detailed description
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with R/R aggressive B-NHL not achieving CMR after standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to IC chemotherapy.The phase 2 component of the study will consist of up to a 28-day screening period, approximately 70 to 112 days of study treatment, a 30-day (+/- 3days) safety follow up, and long-term follow up that will conclude with the final analysis of the phase 3 component, estimated at 30 months after initiation of the phase 3 component. For the phase 3 component, the study will consist of up to a 28-day screening period, a treatment period of up to approximately 168 days, a 30-day safety follow-up visit, and long-term follow up. Long-term follow up will conclude with the final analysis.In the phase 2 component, enrolled subjects will receive blinatumomab monotherapy. In the phase 3 component, enrolled subjects will be randomized in a 1:1 ratio to blinatumomab or IC chemotherapy. In March 2019, decision made to not proceed with phase 3.
Interventions
DRUGBlinatumomab
Blinatumomab monotherapy
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR) | Up to 12 weeks after first dose of blinatumomab | Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification. |
| Phase 3: Number of Participants Who Achieved Complete Metabolic Response (CMR) | Up to 12 weeks after first dose of study treatment | Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Progression Free Survival (PFS) | From first dose of blinatumomab until the end of study, up to 30 months | 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. |
| Phase 2: Duration of Response (DOR) | From first dose of blinatumomab up to 12 weeks | 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. |
| Phase 2: Percentage of Participants Who Experienced Successful Mobilization | From first dose of blinatumomab until the end of study, up to 30 months | 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. |
| Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT) | From baseline HSCT until the end of study, up to 30 months | 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. |
| 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 | 100 days after HSCT | 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. |
| Phase 2: Blinatumomab Steady State Concentrations (Css) | Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days) | 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. |
| Phase 2: Blinatumomab Clearance (CL) | Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days) | 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. |
| Phase 2: Half-life of Blinatumomab | Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days) | — |
| Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days | 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. |
| Phase 3: Objective Response Rate (ORR) | Up to 12 weeks after first dose of study treatment | — |
| Phase 2: Overall Survival (OS) | From randomization until the end of study, up to 30 months | OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using Kaplan-Meier estimates. |
| Phase 3: Duration of Response (DOR) | From first dose of study treatment up to 12 weeks | — |
| Phase 3: Percentage of Participants Who Experienced Successful Mobilization | From baseline until the end of study, up to 30 months | — |
| Phase 3: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT) | From baseline HSCT until the end of study, up to 30 months | — |
| Phase 3: Percentage of Participants Who Died Within 100 Days After Hematopoietic Stem Cell Transplantation (HSCT) That Was Not Due to Relapse | 100 days after HSCT | — |
| Phase 3: Change From Baseline in Patient Reported Clinical Outcome Assessments Quality of Life (QOLCOA) Scores | Up to 30 days after last dose after study treatment | — |
| Phase 3: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | From first dose of study treatment until 30 days after last dose | — |
| Phase 3: Serum Blinatumomab Steady State Concentration (Css) | 24 hours after first dose of blinatumomab | — |
| Phase 3: Blinatumomab Clearance (CL) | Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days) | — |
| Phase 3: Half-life of Blinatumomab | Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days) | — |
| Phase 3: Progression Free Survival (PFS) | From first dose of study treatment until the end of study, up to 30 months | — |
| Phase 2: Objective Response Rate (ORR) | Up to 12 weeks after first dose of blinatumomab | 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. |
Countries
Australia, Belgium, Canada, Italy, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 19 research centers in Australia, Belgium, Italy, Spain, the United Kingdom, and the United States from 23 January 2017 to 15 January 2018.
Pre-assignment details
Phase 3 part of the study was not initiated after Phase 2 data was reviewed. No participants were screened or enrolled for Phase 3.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase 2 | Death | 24 | 0 | 0 |
| Phase 2 | Lost to Follow-up | 1 | 0 | 0 |
| Phase 2 | Withdrawal by Subject | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Phase 2: Blinatumomab |
|---|---|
| Age, Continuous | 54.7 Years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 25 / 41 |
| other Total, other adverse events | 29 / 41 |
| serious Total, serious adverse events | 20 / 41 |
Outcome results
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.
Time frame: Up to 12 weeks after first dose of blinatumomab
Population: FAS: All participants who received blinatumomab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR) | 22.0 Percentage of participants |
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.
Time frame: Up to 12 weeks after first dose of study treatment
Population: 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.
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.
Time frame: Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Population: PK analysis Set: All subjects who received any infusion of blinatumomab and had at least one PK sample collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Blinatumomab Clearance (CL) | 1.78 Liter/hour (L/hr) | Standard Deviation 0.747 |
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.
Time frame: Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Population: PK analysis Set: All subjects who received blinatumomab at each individual dose and had at least one PK sample collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Blinatumomab Steady State Concentrations (Css) | 249 Picograms/millilter (pg/mL) | Standard Deviation 200 |
| Phase 3: Investigator's Choice (IC) Chemotherapy | Phase 2: Blinatumomab Steady State Concentrations (Css) | 804 Picograms/millilter (pg/mL) | Standard Deviation 513 |
| Phase 2: Blinatumomab 112 µg/Day | Phase 2: Blinatumomab Steady State Concentrations (Css) | 3470 Picograms/millilter (pg/mL) | Standard Deviation 3700 |
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.
Time frame: 100 days after HSCT
Population: AutoHSCT Analysis Set: All participants who achieved a response and underwent autoHSCT while in remission and without any other anti-cancer treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Blinatumomab | 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 | 0.0 Percentage of participants |
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.
Time frame: From first dose of blinatumomab up to 12 weeks
Population: Full Analysis Set (FAS): All participants who received blinatumomab.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Duration of Response (DOR) | 6.1 Months |
Secondary
Phase 2: Half-life of Blinatumomab
Time frame: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Population: 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.
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.
Time frame: From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAEs | 41 Participants |
| Phase 2: Blinatumomab | Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Grade ≥ 2 TEAEs | 37 Participants |
| Phase 2: Blinatumomab | Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Grade ≥ 3 TEAEs | 29 Participants |
| Phase 2: Blinatumomab | Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Grade ≥ 4 TEAEs | 12 Participants |
| Phase 2: Blinatumomab | Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Serious TEAEs | 20 Participants |
| Phase 2: Blinatumomab | Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAEs leading to discontinuation of blinatumomab | 7 Participants |
| Phase 2: Blinatumomab | Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAEs leading to interruption of blinatumomab | 13 Participants |
| Phase 2: Blinatumomab | Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Fatal TEAEs | 7 Participants |
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.
Time frame: Up to 12 weeks after first dose of blinatumomab
Population: FAS: All participants who received blinatumomab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Objective Response Rate (ORR) | 36.6 Percentage of participants |
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.
Time frame: From randomization until the end of study, up to 30 months
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Overall Survival (OS) | 11.2 Months |
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.
Time frame: From first dose of blinatumomab until the end of study, up to 30 months
Population: Responder Analysis Set: All participants who had a CMR or PMR per central review during the first 12 weeks after initiation of blinatumomab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Percentage of Participants Who Experienced Successful Mobilization | 40.0 Percentage of 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.
Time frame: From baseline HSCT until the end of study, up to 30 months
Population: FAS: All participants who received blinatumomab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT) | AlloHSCT | 6.7 Percentage of participants |
| Phase 2: Blinatumomab | Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT) | AutoHSCT | 53.3 Percentage of participants |
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.
Time frame: From first dose of blinatumomab until the end of study, up to 30 months
Population: FAS: All participants who received blinatumomab.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Blinatumomab | Phase 2: Progression Free Survival (PFS) | 2.9 Months |
Secondary
Phase 3: Blinatumomab Clearance (CL)
Time frame: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Change From Baseline in Patient Reported Clinical Outcome Assessments Quality of Life (QOLCOA) Scores
Time frame: Up to 30 days after last dose after study treatment
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Duration of Response (DOR)
Time frame: From first dose of study treatment up to 12 weeks
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Half-life of Blinatumomab
Time frame: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: From first dose of study treatment until 30 days after last dose
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Objective Response Rate (ORR)
Time frame: Up to 12 weeks after first dose of study treatment
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Percentage of Participants Who Died Within 100 Days After Hematopoietic Stem Cell Transplantation (HSCT) That Was Not Due to Relapse
Time frame: 100 days after HSCT
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Percentage of Participants Who Experienced Successful Mobilization
Time frame: From baseline until the end of study, up to 30 months
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Time frame: From baseline HSCT until the end of study, up to 30 months
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Progression Free Survival (PFS)
Time frame: From first dose of study treatment until the end of study, up to 30 months
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.
Secondary
Phase 3: Serum Blinatumomab Steady State Concentration (Css)
Time frame: 24 hours after first dose of blinatumomab
Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.