Trial · NCT06124157
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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. |
| Secondary | Rates of EOC/TP2 MRD negativity for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes | From EOC to TP2 | Defined as \<1x10\^-4 or \<0.01% for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes. |
| Other | Rates of end of induction (EOI)/timepoint 1 (TP1) bone marrow MRD negativity with the introduction of dasatinib | From EOI to TP1 | Defined as \<1x10-4 or \<0.01% with the introduction of the relevant TKI during Induction for patients with Ph+ B-ALL. |
| Other | Outcomes of patients with Ph+ and Ph-like ABL-class B-ALL who are removed from protocol therapy due to consolidation failure | Up to 3 years | Will be collected and described. A secondary analysis will also be conducted, examining the EFS of patients in both arms of the randomization using conventional definition of consolidation failure (EOC/TP2 MRD ≥ 1%). |
| Other | Percentage of patients with Ph+ and ABL-class Ph-like B-ALL who continue TKI beyond protocol-prescribed therapy and their outcomes | Up to 3 years | Will be collected and described. |
| Other | Outcomes for patients with Ph+ and ABL-class Ph-like B-ALL who continue TKI beyond protocol-prescribed therapy | Up to 3 years | EFS will be estimated at 3 years. |
| Other | Prognostic significance of MRD by next-generation sequencing (NGS) at end of induction and end of consolidation | Up to 3 years | Its association with outcomes will be explored. |
| Other | Clinical characteristics and outcomes of patients with chronic myeloid leukemia-like biology | Up to 3 years | Will be summarized using descriptive statistics. |
| Other | Immune function of Ph+ and ABL-class Ph-like B-ALL patients | Up to 3 years | Will be summarized using descriptive statistics. |
| Other | TKI levels in the plasma and cerebrospinal fluid of children with Ph+ and ABL-class Ph-like B-ALL | Up to 3 years | Will be summarized using descriptive statistics. |
| Other | Impact of TKIs and high-dose methotrexate interaction and identify clinical and biologic factors influencing methotrexate clearance | Up to 3 years | Will be assessed by summarizing frequencies observed of the same. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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