Trial · NCT06124157
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
NCT06124157, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL). Trials, record NCT06124157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06124157
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
- NCT number
- NCT06124157
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 222 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- B Acute Lymphoblastic Leukemia
- Interventions
Biospecimen Collection, Blinatumomab, Bone Marrow Biopsy, Calaspargase Pegol, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin, Doxorubicin, Echocardiography Test, Imatinib, Leucovorin, Mercaptopurine, Methotrexate, Multigated Acquisition Scan, Pegaspargase, Prednisolone, Prednisone, Radiation Therapy, Thioguanine, Vincristine
- First posted
- 2023-11-09
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS) | Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years | Will be assessed in children, adolescents, and young adults \<25 years old with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B acute lymphoblastic leukemia (B-ALL) who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib. Will be estimated using the Kaplan-Meier method with standard errors of Peto. |
| Primary | ABL-class Ph-like B-ALL 3-year event free survival (EFS) | Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years | Will be assessed in children, adolescents, and young adults \<25 years old with newly-diagnosed ABL-class Ph-like B-ALL who are treated with a modified BFM chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous imatinib for those with PDGFRB gene fusions or dasatinib for those without PDGFRB gene fusions. Will be estimated using the Kaplan-Meier method with standard errors of Peto. |
| Primary | Incidence of adverse events | Up to 3 years | Will assess the safety and toxicity profile (infections, mucositis, neurotoxicity, cytokine release syndrome, hypogammaglobulinemia, therapy delays \> 14 days, and treatment-related mortality) for patients with Ph+ or ABL-class Ph-like B-ALL treated on this novel chemo-immunotherapy backbone with continuous tyrosine kinase inhibitor (TKI). Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. |
| Secondary | 3-year overall survival (OS) | Time from enrollment to death from any cause or date of last contact for those who are alive, assessed up to 3 years | Will be assessed in patients with Ph+ and ABL-class Ph-like B-ALL, respectively. Will be estimated using the Kaplan-Meier method with standard errors of Peto. |
| Secondary | 3-year EFS | Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years | Will be estimated using the Kaplan-Meier method with standard errors of Peto. |
| Secondary | 3-year disease free survival | Time from end of consolidation/blinatumomab block 2 (TP2) for early responders to first event (relapse, second malignancy, or death in complete remission) or last contact for those who are event-free, assessed up to 3 years | Will be estimated using the Kaplan-Meier method with standard errors of Peto. |
| Secondary | Cumulative incidence rates of relapse | Up to 3 years | Will be estimated using Gray's method. |
| Secondary | Treatment related mortality | Up to 3 years | Will be estimated at the end of therapy. |
| Secondary | OS of patients with ABL-class Ph-like B-ALL | Time from enrollment to death from any cause or date of last contact for those who are alive, assessed up to 3 years | Will be stratified by their underlying ABL-class fusion subtypes. |
| Secondary | Rates of end of Consolidation (EOC)/timepoint 2 (TP2) minimal residual disease (MRD) negativity for patients with Ph+ B-ALL | From EOC to TP2 | Defined as \<1x10\^-4 or \<0.01% for patients with Ph+ B-ALL. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source 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/NCT06124157
GET https://conductscience.org/api/trials/v1/NCT06124157/registered