Trial · NCT07228273
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants achieving measurable residual disease negative composite complete remission (CRc-MRD-) | Up to 30 days post last dose of study drug | Will be defined as the achievement of both measurable disease negative (MRD-) by multiparameter flow cytometry and complete response (CR), CR with partial hematologic recovery (CRh), or CR with incomplete blood count recovery (CRi). Participants who do not qualify as efficacy-evaluable (usually due to early death or withdrawal because of toxicity) will be considered non-responders. A point estimate and 95% exact confidence interval (CI) for CRc MRD- will be computed for each arm (and time point) separately and the CRc MRD- rate will be statistically compared across arms with Fisher's exact test at 3 timepoints: end of induction, end of the first consolidation cycle, and end of treatment. A Hochberg multiplicity adjustment will be applied to the p-values from these 3 Fisher exact tests to control the family wise error rate (at α=0.05) for between-arm comparisons of the primary endpoint. CRc MRD- status at each of the above-specified time points will be modeled with logistic regression. |
| Secondary | Percentage of participants achieving CR | Up to 30 days post last dose of study drug | Will be computed for each arm separately in both the safety set and the efficacy set. Will be presented with a point estimate and exact binomial 95% CI. will also be modeled with logistic regression with baseline patient and disease features as predictors and results considered hypothesis-generating. |
| Secondary | Percentage of participants achieving composite complete remission (CRc) | Up to 30 days post last dose of study drug | CRc will be defined as the achievement of CR, CRh, or CRi. Will be computed for each arm separately in both the safety set and the efficacy set. Will be presented with a point estimate and exact binomial 95% CI. will also be modeled with logistic regression with baseline patient and disease features as predictors and results considered hypothesis-generating. |
| Secondary | Percentage of participants achieving an overall response (ORR) | Up to 30 days post last dose of study drug | Will be defined as the proportion of participants who attain a partial remission (PR) or better (i.e., CR, CRh, CRi, morphologic leukemia-free state, or PR) after receiving study treatment. Will be computed for each arm separately in both the safety set and the efficacy set and presented with point estimate and exact binomial 95% CI. Will also be modeled with logistic regression with baseline patient and disease features as predictors and results considered hypothesis-generating. |
| Secondary | Incidence of treatment-emergent grade ≥ 3 adverse events (AEs) | Up to 30 days after the last dose of any study drug | Will be assessed using Common Terminology Criteria for Adverse Events version 5.0. The incidence of specific grade ≥ 3 AEs will be reported with frequencies and percentages, at the overall participant level and by grade, attribution (i.e., a separate table for treatment-related AEs), and seriousness (i.e., separate tables for serious adverse events). |
| Secondary | Event free survival (EFS) | From cycle (C)1 day(D)1 to first occurrence of treatment failure, disease progression, or death due to any cause, assessed up to 2 years | If these events do not occur prior to end of study (EOS), participant is censored at date of last disease assessment. Will be estimated for the efficacy set using the Kaplan-Meier method, with median EFS and EFS rates at common landmark times (e.g., 6 months, 1 year, 2 years) presented with 95% log-log CIs. Cox models will be fit to EFS to assess the impact of baseline patient and disease features, with model results (i.e., hazard ratios and Wald test p-values) interpreted as hypothesis-generating. |
| Secondary | Overall survival (OS) | From C1D1 to date of death due to any cause, assessed up to 2 years | If no death occurs prior to EOS, participant is censored at last known alive date. Will be computed in each arm for both the safety set and the efficacy set. Will be estimated with the Kaplan-Meier method. Median OS and OS rates at common landmark times (e.g., 1 year, 2 years) will be estimated with 95% log-log CIs. For each of the two specified analysis sets, Cox models will be fit to OS to assess the impact of baseline patient and disease features and hematopoietic stem cell transplant (HSCT) as a time-dependent covariate, with results considered hypothesis generating. |
| Secondary | Time to HSCT referral | Up to 2 years after end of study treatment | Within each arm and for both the safety and efficacy sets (separately), cumulative incidence functions (CIFs) will be used to estimate the post-C1D1 time to HSCT referral with death considered a competing risk and patients lacking these bone marrow transplant (BMT) preparation related events being censored at EOS. Between arm differences in time to each of these HSCT-preparatory events will be computed using Gray's test. For each participant cohort (i.e., within each arm for both the safety and efficacy sets), the proportion of patients who are referred to HSCT will be computed with point estimate and 95% exact binominal CI. Fisher's exact test will be employed to test for an association between the occurrence of each HSCT-preparatory event and study arm. |
| Secondary | Time to completed consult for HSCT | Up to 2 years after end of study treatment | Within each arm and for both the safety and efficacy sets (separately), CIFs will be used to estimate the post-C1D1 time to HSCT consultation with death considered a competing risk and patients lacking these BMT preparation related events being censored at EOS. Between arm differences in time to each of these HSCT-preparatory events will be computed using Gray's test. For each participant cohort (i.e., within each arm for both the safety and efficacy sets), the proportion of patients who complete a HSCT consult will be computed with point estimate and 95% exact binominal CI. Fisher's exact test will be employed to test for an association between the occurrence of each HSCT-preparatory event and study arm. |
| Secondary | Percentage of participants who transition to HSCT | Up to 2 years after end of study treatment | Will be computed on both the safety and efficacy sets within each study arm. Besides a point estimate and exact binominal 95% CI for the proportion of patients proceeding to HSCT at any time or within 100 days of commencing study therapy, time-to-HSCT (measured from C1D1) will be estimated within each arm using a CIF, tested across arms with Gray's test, and modeled with Fine-Gray regressions (with baseline patient and disease features as predictors and results considered as hypothesis-generating). For these analyses, pre-HSCT deaths will be considered a competing risk and patients alive but not transplanted will be censored when going off-study. |
| Secondary | Cumulative incidence of HSCT | Up to 2 years after end of study treatment | Will be computed on both the safety and efficacy sets within each study arm. Besides a point estimate and exact binominal 95% CI for the proportion of patients proceeding to HSCT at any time or within 100 days of commencing study therapy, time-to-HSCT (measured from C1D1) will be estimated within each arm using a CIF, tested across arms with Gray's test, and modeled with Fine-Gray regressions (with baseline patient and disease features as predictors and results considered as hypothesis-generating). For these analyses, pre-HSCT deaths will be considered a competing risk and patients alive but not transplanted will be censored when going off-study. |
| Secondary | Percentage of participants who are MRD- post-HSCT | From HSCT day 0 to day +365 post-HSCT | Will be estimated along with an exact binomial 95% CI. |
| Secondary | Cumulative incidence of grade 2-3 post-HSCT infections | From HSCT day 0 to day +100 post-HSCT | Will be assess moderate and severe bacterial, viral, and fungal infections according to Blood and Marrow Transplant Clinical Trials Network criteria. Will be estimated with a CIF (considering death as a competing risk). |
| Secondary | Cumulative incidence of grade ≥ II acute graft versus host disease (aGVHD) | From HSCT day 0 to day +365 post-HSCT | Will be assessed using the Mount Sinai Acute Graft Versus Host Disease International Consortium (MAGIC) criteria. Will be estimated with a CIF (considering death as a competing risk). |
| Secondary | Cumulative incidence of grade ≥ 2 (cGVHD) | From HSCT day 0 to day +365 post-HSCT | Will be assessed using the National Institutes of Health consensus criteria. Will be estimated with a CIF (considering death as a competing risk). |
| Secondary | GVHD-free, relapse-free survival (GRFS) | From HSCT day 0 to disease relapse, MAGIC grade III-IV aGVHD, cGVHD requiring systemic therapy, death from any cause or last known alive, or day + 365 post-HSCT, whichever occurs earliest | Will be computed and reported for the transplanted population from the time of transplant to a qualifying event. Data from participants without any of the specified GRFS events will be censored at the date of the last disease assessment or the date of the last GVHD assessment, whichever occurs earlier. GRFS will be presented with a point estimate and exact binomial CI. |
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.
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