Trial · NCT02883049
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT02883049, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2024-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations. Trials, record NCT02883049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02883049
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
- NCT number
- NCT02883049
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,949 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Central Nervous System Leukemia, Testicular Leukemia
- Interventions
Clofarabine, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Etoposide, Hydrocortisone Sodium Succinate, Laboratory Biomarker Analysis, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Prednisone, Radiation Therapy, Thioguanine, Vincristine Sulfate
- First posted
- 2016-08-30
- Last updated
- 2026-06-02
- Results first posted
- 2024-03-12
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone | At 5 years | DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. Compared using 2-sided log rank test, alpha = 5%. (Completed effective March 19, 2018) |
| Primary | DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1) | At 4 years | (Completed effective February 15, 2017) DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. Compared using a 1-sided log rank test, alpha of 2.5%. |
| Secondary | Toxicity and Tolerability of Post-induction Age-adjusted ITT Compared to Age-adjusted IT MTX in Children With HR B-ALL | Up to 10 years | (Completed effective March 19, 2018) Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, will be estimated for each randomized arm. |
| Secondary | Toxicity and Tolerability of Experimental Arm 1 and Control Arm in Patients With VHR B-ALL | Up to 10 years | Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, will be estimated for each randomized arm. (Closed effective February 15, 2017) |
| Secondary | Induction Mortality in Patients With DS and HR B-ALL Treated With Modified Induction | At 1 month | Percentage of deaths in induction will be calculated. |
| Secondary | 5-year DFS in Patients With Down Syndrome (DS) and HR B-ALL Treated With Modified Induction and Post-Induction Therapy Regimen With MBFM-IMIDM | At 5 years | DFS time is defined as time from end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. 5-year DFS will be estimated using the Kaplan-Meier method. |
| Secondary | DFS for Children and Young Adults With Ph-like B-ALL and a Predicted Tyrosine Kinase Inhibitor (TKI)-Sensitive Mutation Treated With Dasatinib Plus MBFM-IMHDM | Up to 4 years | DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. 4-year DFS will be estimated using the Kaplan-Meier method. |
| Secondary | Toxicity and Tolerability of MBFM-interim Maintenance Intermediate Dose Methotrexate (IMIDM) in Children With Down Syndrome | Up to 10 years | Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, will be estimated. |
| Secondary | Overall Survival (OS) Rate for HR B-ALL Patients, Overall and by Randomized Arm | At 5 years | OS time is defined as time from enrollment to death or date of last contact for patients who are alive. 5-year OS will be estimated for the two randomized arms using the Kaplan-Meier method. |
| Secondary | Overall Survival (OS) Rate for VHR B-ALL Patients, Overall and by Randomized Arm. | At 4 years | OS of VHR-B-ALL post-Induction patients who receive a modified MBFM-IMHDM regimen that contains a second IM (Control Arm) compared to patients receive the cyclophosphamide + etoposide containing regimen (Experimental Arm 1). OS time is defined as time from enrollment to death or date of last contact for patients who are alive. 4-year OS will be estimated for the two randomized arms using the Kaplan-Meier method. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone | At 5 years | Non-DS HR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis. | Percentage of patients | NUMBER |
| PRIMARY | DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1) | At 4 years | Non-DS VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Toxicity and Tolerability of Post-induction Age-adjusted ITT Compared to Age-adjusted IT MTX in Children With HR B-ALL | Up to 10 years | Patients risk assigned as HR B-ALL and randomized to the two post induction therapies (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Toxicity and Tolerability of Experimental Arm 1 and Control Arm in Patients With VHR B-ALL | Up to 10 years | (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Induction Mortality in Patients With DS and HR B-ALL Treated With Modified Induction | At 1 month | Patients with DS and HR B-ALL treated with modified Induction | Percentage of patients | NUMBER |
| SECONDARY | 5-year DFS in Patients With Down Syndrome (DS) and HR B-ALL Treated With Modified Induction and Post-Induction Therapy Regimen With MBFM-IMIDM | At 5 years | Patients with DS and HR B-ALL treated with modified Induction and post induction therapy with MBFM-IMIDM. Inevaluable patients were excluded from analysis | Percentage of patients | NUMBER |
| SECONDARY | DFS for Children and Young Adults With Ph-like B-ALL and a Predicted Tyrosine Kinase Inhibitor (TKI)-Sensitive Mutation Treated With Dasatinib Plus MBFM-IMHDM | Up to 4 years | Patients with Ph-like B-ALL and a predicted tyrosine kinase inhibitor (TKI)-sensitive mutation treated with dasatinib plus MBFM-IMHDM | Percentage of patients | NUMBER |
| SECONDARY | Toxicity and Tolerability of MBFM-interim Maintenance Intermediate Dose Methotrexate (IMIDM) in Children With Down Syndrome | Up to 10 years | DS patients received MBFM-interim maintenance intermediate dose methotrexate (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) Rate for HR B-ALL Patients, Overall and by Randomized Arm | At 5 years | Total HR B-ALL patients (includes patients from AALL0932). Inevaluable and ineligible patients were excluded from analysis. | Percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) Rate for VHR B-ALL Patients, Overall and by Randomized Arm. | At 4 years | VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Experimental Arm 2 was closed early in the study due to excessive toxicities. The objectives and study design for VHR patients was modified to be limited to the two arms (Control vs Experimental Arm 1). Inevaluable and ineligible patients were also excluded from analysis. | Percentage of patients | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone | Non-DS HR B-ALL Arm A | 92.48 | 95% Confidence Interval 90.7 to 94.3 | Percentage of patients | |
DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone | Non-DS HR B-ALL Arm B | 92.33 | 95% Confidence Interval 90.5 to 94.2 | Percentage of patients | |
DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1) | Non-DS VHR B-ALL Control Arm | 77.11 | 95% Confidence Interval 72.4 to 81.8 | Percentage of patients | |
DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1) | Non-DS VHR B-ALL Exp Arm1 | 76.75 | 95% Confidence Interval 72.8 to 80.7 | Percentage of patients | |
| Toxicity and Tolerability of Post-induction Age-adjusted ITT Compared to Age-adjusted IT MTX in Children With HR B-ALL | Non-DS HR B-ALL Arm A | 62.44 | 95% Confidence Interval 59.2 to 65.7 | Percentage of patients | |
| Toxicity and Tolerability of Post-induction Age-adjusted ITT Compared to Age-adjusted IT MTX in Children With HR B-ALL | Non-DS HR B-ALL Arm B | 63.39 | 95% Confidence Interval 60.2 to 66.6 | Percentage of patients | |
| Toxicity and Tolerability of Experimental Arm 1 and Control Arm in Patients With VHR B-ALL | Non-DS VHR B-ALL Control Arm | 66.27 | 95% Confidence Interval 61.2 to 71.3 | Percentage of patients | |
| Toxicity and Tolerability of Experimental Arm 1 and Control Arm in Patients With VHR B-ALL | Non-DS VHR B-ALL Exp Arm1 | 73.16 | 95% Confidence Interval 69.2 to 77.1 | Percentage of patients | |
| Induction Mortality in Patients With DS and HR B-ALL Treated With Modified Induction | DS HR B-ALL (Induction) | 3.57 | 95% Confidence Interval 1.1 to 6.0 | Percentage of patients | |
| 5-year DFS in Patients With Down Syndrome (DS) and HR B-ALL Treated With Modified Induction and Post-Induction Therapy Regimen With MBFM-IMIDM | DS HR B-ALL | 71.78 | 95% Confidence Interval 65.7 to 77.8 | Percentage of patients |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow96
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Non-DS B-ALL | 4,749 | |
| Induction | STARTED | DS B-ALL | 224 | |
| Induction | STARTED | Patients Transferred From AALL0932 | 0 | |
| Induction | STARTED | Non-DS HR B-ALL Arm A | 0 | |
| Induction | STARTED | Non-DS HR B-ALL Arm B | 0 | |
| Induction | STARTED | Non-DS HR B-ALL From AALL0932 Arm A | 0 | |
| Induction | STARTED | Non-DS HR B-ALL From AALL0932 Arm B | 0 | |
| Induction | STARTED | Non-DS VHR B-ALL Control Arm | 0 | |
| Induction | STARTED | Non-DS VHR B-ALL Experimental Arm 1 | 0 | |
| Induction | STARTED | Non-DS VHR B-ALL Experimental Arm 2 | 0 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 participant flowAdverse events8,848
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 | Non-DS B-ALL | 9 | 4,714 | 9 |
| other | Anemia | Blood and lymphatic system disorders | DS B-ALL | 3 | 223 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Patients Transferred From AALL0932 | 0 | 0 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Non-DS HR B-ALL Arm A | 2 | 526 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Non-DS HR B-ALL Arm B | 5 | 528 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Non-DS HR B-ALL From AALL0932 Arm A | 1 | 348 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Non-DS HR B-ALL From AALL0932 Arm B | 2 | 345 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Non-DS VHR B-ALL Control Arm | 0 | 282 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Non-DS VHR B-ALL Experimental Arm 1 | 1 | 369 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Non-DS VHR B-ALL Experimental Arm 2 | 1 | 73 | 1 |
1 to 10 of 8,848Source ClinicalTrials.gov
See all 8,848 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-DS B-ALL | 78 | 4,714 |
| Total, all-cause mortality | DS B-ALL | 8 | 223 |
| Total, all-cause mortality | Patients Transferred From AALL0932 | 0 | 0 |
| Total, all-cause mortality | Non-DS HR B-ALL Arm A | 23 | 526 |
| Total, all-cause mortality | Non-DS HR B-ALL Arm B | 24 | 528 |
| Total, all-cause mortality | Non-DS HR B-ALL From AALL0932 Arm A | 6 | 348 |
| Total, all-cause mortality | Non-DS HR B-ALL From AALL0932 Arm B | 11 | 345 |
| Total, all-cause mortality | Non-DS VHR B-ALL Control Arm | 48 | 282 |
| Total, all-cause mortality | Non-DS VHR B-ALL Experimental Arm 1 | 57 | 369 |
| Total, all-cause mortality | Non-DS VHR B-ALL Experimental Arm 2 | 15 | 73 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 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.
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