Trial · NCT02393859
Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
NCT02393859, Phase 3, Completed, Amgen; results first posted 2020-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL). Trials, record NCT02393859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02393859
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
- NCT number
- NCT02393859
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 111 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Leukemia, Acute Lymphoblastic
- Interventions
- Blinatumomab, Dexamethasone, Vincrisitne, Daunorubicin, Methotrexate, Ifosfamide, PEG-asparaginase, Erwinia-asparaginase
- First posted
- 2015-03-20
- Last updated
- 2026-06-26
- Other registries' IDs
- eudract:2014-002476-92
- Results first posted
- 2020-07-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis) | As of the primary analysis data cutoff date (17 July 2019), overall median follow-up time for EFS was 22.4 months. | EFS is calculated from the time of randomization until the date of relapse or M2 marrow (representative bone marrow aspirate or biopsy with ≥ 5% and \< 25% blasts) after having achieved a complete remission (CR), failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with investigational product (IP) or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date. Participants were said to be in CR when they had the following: * M1 marrow * Peripheral blood without blasts * Absence of extramedullary leukemic involvement Months are calculated as days from randomization date to event/censor date, divided by 30.5. |
| Primary | Kaplan Meier Estimate: EFS (Final Analysis) | At final analysis, overall median follow-up time for EFS was 51.9 months. | EFS is calculated from the time of randomization until the date of relapse or M2 marrow after having achieved a CR, failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with IP or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date. Participants were said to be in CR when they had the following: * M1 marrow * Peripheral blood without blasts * Absence of extramedullary leukemic involvement Months are calculated as days from randomization date to event/censor date, divided by 30.5. |
| Secondary | Kaplan Meier Estimate: Overall Survival (OS) | At final analysis, overall median follow-up time for OS was 55.2 months. | 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. Months were calculated as days from randomization date to event/censor date, divided by 30.5. |
| Secondary | Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation | Up to End of Treatment (Cycle 1, Day 29) | At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. MRD response was defined as MRD level \< 10\^-4, by polymerase chain reaction (PCR) or flow cytometry, at the end of treatment (Cycle 1 Day 29) with study drug. Participants who were part of the MRD Evaluable Set and were missing the end of treatment (Cycle 1 Day 29) assessment for a respective MRD assessment method were considered not to have achieved a response. |
| Secondary | Cumulative Incidence of Relapse (CIR) | At final analysis, the overall maximum follow-up time was 82.0 months. | CIR estimate, presented as median months to relapse, calculated from date of achievement of first CR, using the cumulative incidence method (Fine JP, Gray RJ:1999). Deaths prior to relapse not considered related to an otherwise undocumented relapse were treated as a competing risk. Participants still alive without a date of relapse were censored at the time of last follow-up. Relapse=presence of ≥1 of the following: * isolated bone marrow relapse (M3 marrow \[representative bone marrow aspirate or biopsy with ≥25% blasts\] in the absence of extramedullary involvement) * combined bone marrow relapse (M2 \[representative bone marrow aspirate or biopsy with ≥5% and \<25% blasts\] or M3 marrow and ≥1 extramedullary manifestation of acute lymphoblastic leukemia) * central nervous system extramedullary relapse * testicular extramedullary relapse * extramedullary relapse at other sites Months were calculated as days from randomization to event/censor date, divided by 30.5. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) | From first dose of IP through the last dose of IP (up to Day 29) plus 30 days. | Adverse event (AE): any untoward medical occurrence. Serious AE: an AE meeting at least 1 of the following serious criteria: fatal; life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Severity was graded according to the Common Terminology Criteria for AEs (CTCAE) version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Investigational product (IP) in the HC3 arm refers to dexamethasone, methotrexate, daunorubicin, erwinase, ifosfamide, asparaginase, and vincristine, and in the blinatumomab arm refers to blinatumomab. Treatment-related refers to the assessment of a relationship between IP and the event. |
| Secondary | Number of Participants With TEAEs of Interest | From first dose of IP through the last dose of IP (up to Day 29) plus 30 days. | TEAEs of interest included capillary leak syndrome (CLS), cytokine release syndrome (CRS), decreased immunoglobulins (DI), elevated liver enzymes (ELE), embolic and thrombotic events (ETE), infections (INF), infusion reactions without considering duration (IRWCD), medication errors (ME), neurologic events (NE), neutropenia and febrile neutropenia (NFN), pancreatitis (PNC), tumor lysis syndrome, leukoencephalopathy, immunogenicity. Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. |
| Secondary | Number of Participants With Shifts From Baseline Grade 0 or 1 to Worst Postbaseline Grade 3 or 4 Clinical Chemistry and Hematology Values | Up to Day 29 (± 2 days). | Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Increases (↑) or decreases (↓) in laboratory value grades (Gr) from baseline (BL) to worst postbaseline (→ PB) grade are presented. NA=not available. |
| Secondary | Kaplan-Meier Estimate of 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) | From the date of alloHSCT until death/censor date; median follow up time was 1742.0 days for blinatumomab and 1619.0 days for HC3. | The analysis of 100-day mortality after alloHSCT was assessed for participants who received an alloHSCT while in remission and did not receive any additional anti-leukemic treatment. 100-day mortality after alloHSCT was calculated relative to the date of alloHSCT. The 100-day mortality rate after alloHSCT was defined as the percentage of participants having died up to 100 days after alloHSCT, estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants still alive were censored at the date they were last known to be alive. |
| Secondary | Number of Participants With Anti-Blinatumomab Antibodies Postbaseline (Blinatumomab Arm Only) | Day 1 to Day 29. | Participants receiving blinatumomab had blood samples analyzed for binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies. Participants who were binding antibody-positive or neutralizing antibody-positive post-baseline with a negative or no result at baseline are presented. |
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 | Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis) | As of the primary analysis data cutoff date (17 July 2019), overall median follow-up time for EFS was 22.4 months. | Full Analysis Set: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received (primary analysis population). | months | MEDIAN |
| PRIMARY | Kaplan Meier Estimate: EFS (Final Analysis) | At final analysis, overall median follow-up time for EFS was 51.9 months. | FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received (final analysis population). | months | MEDIAN |
| SECONDARY | Kaplan Meier Estimate: Overall Survival (OS) | At final analysis, overall median follow-up time for OS was 55.2 months. | FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received. | months | MEDIAN |
| SECONDARY | Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation | Up to End of Treatment (Cycle 1, Day 29) | MRD Evaluable Set: participants for whom an evaluable baseline MRD marker can be found with either of the MRD assessment methods of PCR or flow cytometry. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Relapse (CIR) | At final analysis, the overall maximum follow-up time was 82.0 months. | FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) | From first dose of IP through the last dose of IP (up to Day 29) plus 30 days. | Safety Analysis Set: participants who received protocol-specified therapy analyzed according to the treatment they received. | participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs of Interest | From first dose of IP through the last dose of IP (up to Day 29) plus 30 days. | Safety Analysis Set: who received protocol-specified therapy analyzed according to the treatment they received. | participants | NUMBER |
| SECONDARY | Number of Participants With Shifts From Baseline Grade 0 or 1 to Worst Postbaseline Grade 3 or 4 Clinical Chemistry and Hematology Values | Up to Day 29 (± 2 days). | Safety Analysis Set: who received protocol-specified therapy analyzed according to the treatment they received. | participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) | From the date of alloHSCT until death/censor date; median follow up time was 1742.0 days for blinatumomab and 1619.0 days for HC3. | HSCT Analysis Set: participants who underwent an HSCT while in remission without any other anti-leukemic therapy. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Anti-Blinatumomab Antibodies Postbaseline (Blinatumomab Arm Only) | Day 1 to Day 29. | Safety Analysis Set: participants who received protocol-specified therapy analyzed according to the treatment they received. Participants in the blinatumumab arm with a post-baseline result. | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group260
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis) | HC3 Chemotherapy | 7.4 | 95% Confidence Interval 4.5 to 12.7 | months | |
| Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis) | Blinatumomab | NA | 95% Confidence Interval 12.0 to NA | months | |
| Kaplan Meier Estimate: EFS (Final Analysis) | HC3 Chemotherapy | 7.8 | 95% Confidence Interval 5.8 to 13.4 | months | |
| Kaplan Meier Estimate: EFS (Final Analysis) | Blinatumomab | NA | 95% Confidence Interval 24.8 to NA | months | |
| Kaplan Meier Estimate: Overall Survival (OS) | HC3 Chemotherapy | 25.6 | 95% Confidence Interval 17.5 to NA | months | |
| Kaplan Meier Estimate: Overall Survival (OS) | Blinatumomab | NA | 95% Confidence Interval NA to NA | months | |
| Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation | HC3 Chemotherapy | MRD Response by PCR | 53.1 | 95% Confidence Interval 38.3 to 67.5 | percentage of participants |
| Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation | Blinatumomab | MRD Response by PCR | 93.9 | 95% Confidence Interval 83.1 to 98.7 | percentage of participants |
| Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation | HC3 Chemotherapy | MRD Response by Flow Cytometry | 60.0 | 95% Confidence Interval 45.9 to 73.0 | percentage of participants |
| Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation | Blinatumomab | MRD Response by Flow Cytometry | 92.6 | 95% Confidence Interval 82.1 to 97.9 | percentage of participants |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HC3 Chemotherapy | 57 | |
| Overall Study | STARTED | Blinatumomab | 54 | |
| Overall Study | Participants Treated | HC3 Chemotherapy | 52 | |
| Overall Study | Participants Treated | Blinatumomab | 54 | |
| Overall Study | Participants in the Primary Analysis Population | HC3 Chemotherapy | 54 | |
| Overall Study | Participants in the Primary Analysis Population | Blinatumomab | 54 | |
| Overall Study | Participants in the Final Analysis Population | HC3 Chemotherapy | 57 | |
| Overall Study | Participants in the Final Analysis Population | Blinatumomab | 54 | |
| Overall Study | COMPLETED | HC3 Chemotherapy | 16 | |
| Overall Study | COMPLETED | Blinatumomab | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events186
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 | HC3 Chemotherapy | 24 | 52 | |
| other | Anaemia | Blood and lymphatic system disorders | Blinatumomab | 13 | 54 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | HC3 Chemotherapy | 4 | 52 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Blinatumomab | 3 | 54 | |
| other | Leukopenia | Blood and lymphatic system disorders | HC3 Chemotherapy | 3 | 52 | |
| other | Leukopenia | Blood and lymphatic system disorders | Blinatumomab | 0 | 54 | |
| other | Neutropenia | Blood and lymphatic system disorders | HC3 Chemotherapy | 13 | 52 | |
| other | Neutropenia | Blood and lymphatic system disorders | Blinatumomab | 5 | 54 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | HC3 Chemotherapy | 11 | 52 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Blinatumomab | 4 | 54 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HC3 Chemotherapy | 28 | 57 |
| Total, all-cause mortality | Blinatumomab | 11 | 54 |
| Total, other adverse events | HC3 Chemotherapy | 48 | 52 |
| Total, other adverse events | Blinatumomab | 54 | 54 |
| Total, serious adverse events | HC3 Chemotherapy | 24 | 52 |
| Total, serious adverse events | Blinatumomab | 15 | 54 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HC3 Chemotherapy vs Blinatumomab: deaths from any cause | Trial comparisons |
| HC3 Chemotherapy vs Blinatumomab: serious adverse events | 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02393859
GET https://conductscience.org/api/trials/v1/NCT02393859/results?page=2