Trial · NCT02013167
Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
NCT02013167, Phase 3, Terminated, Amgen; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL). Trials, record NCT02013167. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02013167
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
- NCT number
- NCT02013167
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 405 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
- Interventions
- Blinatumomab, Standard of Care Chemotherapy
- First posted
- 2013-12-17
- Last updated
- 2024-03-05
- Other registries' IDs
- eudract:2013-000536-10
- Results first posted
- 2017-08-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group. | Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive. |
| Secondary | Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation | 12 weeks | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete Remission (CR) was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets \> 100,000/μl, and absolute neutrophil count (ANC) \> 1,000/μl. CR must have occurred within 12 weeks of the first dose of therapy. |
| Secondary | Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation | 12 weeks | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets \> 100,000/μl, and ANC \> 1,000/μl. Complete Remission with partial hematological recovery (CRh\*) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Complete remission with incomplete hematological recovery (CRi) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets \> 100,000/μl or ANC \> 1000 (but not both). |
| Secondary | Event Free Survival (EFS) | 6 months | Event free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh\*/CRi or death, whichever occurred first. Participants who failed to achieve a CR/CRh\*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day. Participants still alive and relapse-free were censored on their last disease assessment date. A relapse event was any one of the following: * Hematological relapse: proportion of blasts in bone marrow \>5% or blasts in peripheral blood after documented CR or CRh\* or CRi * Progressive disease: An increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/μL in the number of circulating leukemia cells * Extramedullary relapse: extramedullary lesion that is new or increased by 50% from nadir as assessed by Cheson criteria. The Kaplan-Meier estimate of EFS at 6 months is reported. |
| Secondary | Duration of Complete Remission | Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.0 months in the blinatumomab group. | Duration of complete remission, calculated only for participants who achieved a CR, was calculated from the date a CR was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date. |
| Secondary | Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) | Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.2 months in the blinatumomab group. | Duration of CR/CRh\*/CRi, calculated only for participants who achieved a CR/CRh\*/CRi, was calculated from the date a CR/CRh\*/CRi was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date. |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation | 12 weeks | Bone marrow samples were evaluated for MRD remission by a central laboratory. MRD remission was defined as the occurrence of an MRD level below 10\^-4 measured by quantitative reverse transcription polymerase chain reaction (PCR) or flow cytometry. |
| Secondary | Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) | Up to the data cut-off date of 04 January 2016; maximum time on study was 23 months. | |
| Secondary | Number of Participants With Adverse Events | From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group. | Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures? |
| Secondary | 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant | 100 days, from the date of allogeneic HSCT until the data cut-off date of 04 January 2016 | The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who achieved a best response of CR/CRh\*CTi within 12 weeks of treatment initiation, who received an allogeneic HSCT and did not receive any additional anticancer treatment before the transplant. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT. The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group. | All randomized participants | months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation | 12 weeks | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation | 12 weeks | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Event Free Survival (EFS) | 6 months | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Duration of Complete Remission | Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.0 months in the blinatumomab group. | Randomized participants with a best response of complete remission within 12 weeks of treatment initiation. | months | MEDIAN |
| SECONDARY | Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) | Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.2 months in the blinatumomab group. | Randomized participants with a best response of CR/CRh\*/CRi within 12 weeks of treatment initiation. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation | 12 weeks | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) | Up to the data cut-off date of 04 January 2016; maximum time on study was 23 months. | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group. | All participants who received protocol-specified therapy analyzed according to the treatment they received. | participants | NUMBER |
| SECONDARY | 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant | 100 days, from the date of allogeneic HSCT until the data cut-off date of 04 January 2016 | Randomized participants with a best response of CR/CRh\*/CRi within 12 weeks of treatment initiation and who received an allogeneic HSC without anti-cancer therapy prior to allogeneic HSCT. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Standard of Care Chemotherapy | 4.0 | 95% Confidence Interval 2.9 to 5.3 | months | |
| Overall Survival | Blinatumomab | 7.7 | 95% Confidence Interval 5.6 to 9.6 | months | |
| Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation | Standard of Care Chemotherapy | 15.7 | 95% Confidence Interval 10.0 to 23.0 | percentage of participants | |
| Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation | Blinatumomab | 33.6 | 95% Confidence Interval 28.0 to 39.5 | percentage of participants | |
Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation | Standard of Care Chemotherapy | 24.6 | 95% Confidence Interval 17.6 to 32.8 | percentage of participants | |
Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation | Blinatumomab | 43.9 | 95% Confidence Interval 37.9 to 50.0 | percentage of participants | |
| Event Free Survival (EFS) | Standard of Care Chemotherapy | 12.5 | 95% Confidence Interval 7.2 to 19.2 | percentage of participants | |
| Event Free Survival (EFS) | Blinatumomab | 30.7 | 95% Confidence Interval 25.0 to 36.5 | percentage of participants | |
| Duration of Complete Remission | Standard of Care Chemotherapy | 7.8 | 95% Confidence Interval 2.2 to 19.0 | months | |
| Duration of Complete Remission | Blinatumomab | 8.3 | 95% Confidence Interval 5.7 to 10.7 | months |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard of Care Chemotherapy | 134 | |
| Overall Study | STARTED | Blinatumomab | 271 | |
| Overall Study | Received Treatment | Standard of Care Chemotherapy | 109 | |
| Overall Study | Received Treatment | Blinatumomab | 267 | |
| Overall Study | COMPLETED | Standard of Care Chemotherapy | 33 | |
| Overall Study | COMPLETED | Blinatumomab | 93 | |
| Overall Study | NOT COMPLETED | Standard of Care Chemotherapy | 101 | |
| Overall Study | NOT COMPLETED | Blinatumomab | 178 |
Source ClinicalTrials.gov
Adverse events498
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care Chemotherapy | 46 | 109 | |
| other | Anaemia | Blood and lymphatic system disorders | Blinatumomab | 69 | 267 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Standard of Care Chemotherapy | 36 | 109 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Blinatumomab | 48 | 267 | |
| other | Neutropenia | Blood and lymphatic system disorders | Standard of Care Chemotherapy | 31 | 109 | |
| other | Neutropenia | Blood and lymphatic system disorders | Blinatumomab | 51 | 267 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Standard of Care Chemotherapy | 32 | 109 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Blinatumomab | 47 | 267 | |
| other | Sinus tachycardia | Cardiac disorders | Standard of Care Chemotherapy | 6 | 109 | |
| other | Sinus tachycardia | Cardiac disorders | Blinatumomab | 15 | 267 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care Chemotherapy | ||
| Total, all-cause mortality | Blinatumomab | ||
| Total, other adverse events | Standard of Care Chemotherapy | 105 | 109 |
| Total, other adverse events | Blinatumomab | 250 | 267 |
| Total, serious adverse events | Standard of Care Chemotherapy | 49 | 109 |
| Total, serious adverse events | Blinatumomab | 165 | 267 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Blinatumomab vs Standard of Care Chemotherapy: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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