Trial · NCT02101853
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
NCT02101853, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2022-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia. Trials, record NCT02101853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02101853
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
- NCT number
- NCT02101853
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 669 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent B Acute Lymphoblastic Leukemia
- Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase, Blinatumomab, Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Leucovorin Calcium, Mercaptopurine, Methotrexate, Mitoxantrone, Mitoxantrone Hydrochloride, Pegaspargase, Pharmacological Study, Radiation Therapy, Therapeutic Hydrocortisone, Thioguanine, Vincristine, Vincristine Sulfate
- First posted
- 2014-04-02
- Last updated
- 2026-10-21
- Results first posted
- 2022-12-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients | Up to 2 years from date of randomization | DFS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). DFS is calculated as the time from randomization to date of first event (treatment failure, relapse, second malignancy, remission death) or date of last contact. Two-year DFS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. |
| Primary | Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients | Up to 3 years from date of randomization | DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. |
| Secondary | Overall Survival (OS) of HR and IR Relapse Patients | Up to 2 years from date of randomization | OS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Two-year OS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. |
| Secondary | Overall Survival (OS) of LR Relapse Patients | Up to 3 years from date of randomization | OS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Three-year OS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. |
| Other | Rates of Minimal Residual Disease (MRD) Positivity (> 0.01%) | Up to 12 weeks | The rates at the end of Block 2 and Block 3 will be calculated for the randomized arms for HR and IR relapse patients. |
| Other | Hematologic Complete Remission Rate (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | The observed rate will be calculated among patients with treatment failure who did not previously receive blinatumomab. |
| Other | MRD Negativity (< 0.01%) Rate (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | The observed rate will be calculated among patients with treatment failure who did not previously receive blinatumomab. |
| Other | Proportion of Patients That Proceed to Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | The observed rate will be calculated among patients with treatment failure who did not previously receive blinatumomab. |
| Other | Feasibility of Rapid Taper of Immune Suppression for Subset of HSCT Patients With MRD >= 0.01% Pre- and/or Post-HSCT With no Acute Graft Versus Host Disease (aGVHD) | Up to 10 years | The observed rate of grade III-IV aGVHD among this subset will be calculated with 95% confidence intervals and compared descriptively to target rate. |
| Other | Safety of Rapid Taper of Immune Suppression for Subset of HSCT Patients With MRD >= 0.01% Pre- and/or Post-HSCT With no aGVHD Defined as < 5% Rate of Treatment-related Mortality (TRM) | Up to 10 years | The observed rate of TRM among this subset will be calculated with 95% confidence intervals and compared descriptively to target rate. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients | Up to 2 years from date of randomization | HR and IR patients randomized per protocol prior to June 30, 2019. This is the cohort of patients who were included in the primary analysis addressing the primary objective on HR/IR patients. Of the total of 216 randomized HR/IR patients, 2 patients with randomization procedure errors and 6 patients randomized after June 30, 2019 were excluded. | percentage of participants | NUMBER |
| PRIMARY | Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients | Up to 3 years from date of randomization | LR patients randomized per protocol. This is the cohort of patients who were included in the primary analysis addressing the primary objective on LR patients. Of the total of 256 randomized LR patients, 1 patient was found to be ineligible and was excluded. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) of HR and IR Relapse Patients | Up to 2 years from date of randomization | HR and IR patients randomized per protocol prior to June 30, 2019. This is the cohort of patients who were included in the primary analysis addressing the primary objective on HR/IR patients. Of the total of 216 randomized HR/IR patients, 2 patients with randomization procedure errors and 6 patients randomized after June 30, 2019 were excluded. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) of LR Relapse Patients | Up to 3 years from date of randomization | LR patients randomized per protocol. This is the cohort of patients who were included in the primary analysis addressing the primary objective on LR patients. Of the total of 256 randomized LR patients, 1 patient was found to be ineligible and was excluded. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Rates of Minimal Residual Disease (MRD) Positivity (> 0.01%) | Up to 12 weeks | |||
| OTHER_PRE_SPECIFIED | Hematologic Complete Remission Rate (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | |||
| OTHER_PRE_SPECIFIED | MRD Negativity (< 0.01%) Rate (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | |||
| OTHER_PRE_SPECIFIED | Proportion of Patients That Proceed to Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab (for Treatment Failure Patients Not Previously Receiving Blinatumomab) | Up to 12 weeks | |||
| OTHER_PRE_SPECIFIED | Feasibility of Rapid Taper of Immune Suppression for Subset of HSCT Patients With MRD >= 0.01% Pre- and/or Post-HSCT With no Acute Graft Versus Host Disease (aGVHD) | Up to 10 years | |||
| OTHER_PRE_SPECIFIED | Safety of Rapid Taper of Immune Suppression for Subset of HSCT Patients With MRD >= 0.01% Pre- and/or Post-HSCT With no aGVHD Defined as < 5% Rate of Treatment-related Mortality (TRM) | Up to 10 years |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients | Arm A (HR and IR Control) | 39.04 | 95% Confidence Interval 29.13 to 48.81 | percentage of participants | |
| Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients | Arm B (HR and IR Blinatumomab) | 54.44 | 95% Confidence Interval 44.30 to 63.51 | percentage of participants | |
| Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients | Arm C (LR Control) | 58.94 | 95% Confidence Interval 49.08 to 67.53 | percentage of participants | |
| Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients | Arm D (LR Blinatumomab) | 67.00 | 95% Confidence Interval 57.36 to 74.94 | percentage of participants | |
| Overall Survival (OS) of HR and IR Relapse Patients | Arm A (HR and IR Control) | 58.40 | 95% Confidence Interval 47.75 to 67.61 | percentage of participants | |
| Overall Survival (OS) of HR and IR Relapse Patients | Arm B (HR and IR Blinatumomab) | 71.33 | 95% Confidence Interval 61.34 to 79.17 | percentage of participants | |
| Overall Survival (OS) of LR Relapse Patients | Arm C (LR Control) | 88.29 | 95% Confidence Interval 80.96 to 92.92 | percentage of participants | |
| Overall Survival (OS) of LR Relapse Patients | Arm D (LR Blinatumomab) | 90.37 | 95% Confidence Interval 82.63 to 94.77 | percentage of participants |
Source ClinicalTrials.gov
Participant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Block 1 Induction | STARTED | Block 1 Induction Therapy | 669 | |
| Block 1 Induction | STARTED | Arm A (HR and IR Control) | 0 | |
| Block 1 Induction | STARTED | Arm B (HR and IR Blinatumomab) | 0 | |
| Block 1 Induction | STARTED | Arm C (LR Control) | 0 | |
| Block 1 Induction | STARTED | Arm D (LR Blinatumomab) | 0 | |
| Block 1 Induction | STARTED | Blinatumomab Salvage Therapy | 0 | |
| Block 1 Induction | COMPLETED | Block 1 Induction Therapy | 494 | |
| Block 1 Induction | COMPLETED | Arm A (HR and IR Control) | 0 | |
| Block 1 Induction | COMPLETED | Arm B (HR and IR Blinatumomab) | 0 | |
| Block 1 Induction | COMPLETED | Arm C (LR Control) | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events3,390
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 | Anemia | Blood and lymphatic system disorders | Block 1 Induction Therapy | 5 | 661 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Arm A (HR and IR Control) | 70 | 109 | 134 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (HR and IR Blinatumomab) | 82 | 107 | 124 |
| other | Anemia | Blood and lymphatic system disorders | Arm C (LR Control) | 86 | 129 | 207 |
| other | Anemia | Blood and lymphatic system disorders | Arm D (LR Blinatumomab) | 95 | 127 | 236 |
| other | Anemia | Blood and lymphatic system disorders | Blinatumomab Salvarage Therapy | 20 | 27 | 33 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Block 1 Induction Therapy | 1 | 661 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm A (HR and IR Control) | 2 | 109 | 3 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm B (HR and IR Blinatumomab) | 1 | 107 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm C (LR Control) | 4 | 129 | 6 |
1 to 10 of 3,390Source ClinicalTrials.gov
See all 3,390 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Block 1 Induction Therapy | 24 | 661 |
| Total, all-cause mortality | Arm A (HR and IR Control) | 9 | 109 |
| Total, all-cause mortality | Arm B (HR and IR Blinatumomab) | 5 | 107 |
| Total, all-cause mortality | Arm C (LR Control) | 3 | 129 |
| Total, all-cause mortality | Arm D (LR Blinatumomab) | 0 | 127 |
| Total, all-cause mortality | Blinatumomab Salvarage Therapy | 2 | 27 |
| Total, other adverse events | Block 1 Induction Therapy | 456 | 661 |
| Total, other adverse events | Arm A (HR and IR Control) | 92 | 109 |
| Total, other adverse events | Arm B (HR and IR Blinatumomab) | 103 | 107 |
| Total, other adverse events | Arm C (LR Control) | 118 | 129 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02101853
GET https://conductscience.org/api/trials/v1/NCT02101853/flow?page=2