Trial · NCT06210750
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (Cohorts 1, 2 and 3) | Up to 10 years | National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events will be used to determine severity of toxicity. |
| Primary | Undetectable minimal residual disease (MRD) (Cohort 1) | At day 29 following induction | There will be three primary analyses, each comparing an experimental arm with the shared control arm using Fisher's exact test with a one-sided alpha of 10%. All eligible randomized participants will be used in the efficacy comparison. |
| Primary | Percent of participants with detectable disease in the bone marrow (Cohort 2) | At diagnosis and at days 29 and 57 | Binomial estimates will be reported along with exact 95% confidence intervals. |
| Primary | Undetectable MRD (Cohorts 1 and 3) | At days 29 and 78 | Binomial estimates will be reported along with exact 95% confidence intervals. |
| Secondary | Rate of complete remission (CR) | End of consolidation therapy | Response rates in each arm and cohort will be calculated and presented with exact binomial 95% confidence intervals. |
| Secondary | Rate of complete remission with incomplete count recovery (CRi) with and without MRD | End of consolidation therapy | Response rates in each arm and cohort will be calculated and presented with exact binomial 95% confidence intervals. |
| Secondary | Event free survival | From the date of initial registration on study until the first of the following events: death from any cause, relapse from MRD-negative remission, or completion of protocol therapy without documentation of MRD-negative remission, up to 10 years | Will be estimated using the method of Kaplan-Meier; randomized arms within Cohort 1 will be compared using the stratified log rank test. |
| Secondary | Relapse free survival | From the date the participant first achieves CR or CRi until relapse from CR/CRi or death from any cause, up to 10 years | Will be estimated using the method of Kaplan-Meier; randomized arms within Cohort 1 will be compared using the stratified log rank test. |
| Secondary | Overall survival | From the day of registration to death from any cause, up to 10 years | Will be estimated using the method of Kaplan-Meier; randomized arms within Cohort 1 will be compared using the stratified log rank test. |
| Secondary | Incidence of adverse events | Up to 10 years | National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events will be used to determine severity of toxicity. |
| Secondary | Serum asparaginase activity levels | At day 8 and day 15 of induction, day 19 and 26 of consolidation and day 6 and 13 of interim maintenance | Of patients with reduced doses Peg-asparaginase in participants age \> 30 years and/or participants with at least one of the following risk factors for toxicity: Body mass index (BMI) \> 30, history of liver disease, history of diabetes mellitus type 2. |
| Secondary | Incidence of adverse events associated with reduced doses of Peg-asparaginase | Up to 10 years | Participants age \>30 years and/or in participants with at least one of risk factors for toxicity. |
| Other | Rates of MRD | At day 29 (all cohorts), day 78 (cohorts 1 and 3), and day 57 (cohort 2) | With centrally evaluated flow cytometry. Binomial estimates will be reported along with exact 95% confidence intervals. |
| Other | Percentage of participants with ETP and non-ETP immunophenotype | Diagnosis | Binomial estimates will be reported along with exact 95% confidence intervals. |
| Other | Association of CR/CRi, event-free survival, relapse-free survival, and overall survival with early thymic precursor (ETP) and non-ETP immunophenotype | Up to 10 years | Response rates will be compared using Fisher's exact test. Survival outcomes will be compared using log-rank tests. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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