Trial · NCT07548983
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (DLTs) | From cycle 1 day 1 (i.e., day +5 post-transplant) to end of cycle 2 (Cycle length = 28 days) | Will determine the safety and tolerability of ruxolitinib monotherapy (part A) and ruxolitinib plus azacitidine therapy (part B). DLTs will be used to identify a maximum tolerated dose. Dose levels will either be de-escalated, escalated, or retained-according to pre calculated Bayesian Optimal Interval decision rules. |
| Primary | Incidence of grade 3+ treatment-related adverse events (TRAEs) (Part B) | Up to 30 days after the end of cycle 9 | TRAEs of grade 3 and higher experienced during treatment with the doublet of ruxolitinib + azacitidine will be reported (with frequencies and percentages) as a co-primary endpoint. TRAEs are defined as adverse events that are definitely or possibly attributable to study treatment. Will be assessed using Common Terminology Criteria for Adverse Events version 5.0, where adverse events are assessed on a scale of 1-5, with higher scores indicating worse outcomes. |
| Secondary | Graft versus host disease (GVHD)-free, relapse-free survival | From date of transplant to disease relapse, grade III-IV acute (a) GVHD, chronic (c) GVHD requiring systemic immunosuppressive therapy, or death from any cause or last known alive (censored), whichever occurs earlier, assessed up to 2 years | Will be estimated by the Kaplan-Meier method, with estimates provided for the median time-to-event (with 95% log-log confidence interval \[CI\]) and event rates (and 95% log-log CIs) at landmark times like 3-, 6-, 12-, and 24-months post-allogeneic hematopoietic stem cell transplant (HSCT). |
| Secondary | Overall survival | From date of transplant to last known alive (censored) or death date, assessed up to 2 years | Will be estimated by the Kaplan-Meier method, with estimates provided for the median time-to-event (with 95% log-log CI) and event rates (and 95% log-log CIs) at landmark times like 3-, 6-, 12-, and 24-months post-allogeneic HSCT. |
| Secondary | Cumulative incidence of neutrophil engraftment | From date of transplant to 30 days post-HSCT | Deaths in the absence of the event of interest will be considered as a competing risk. Cumulative incidence function (CIF) estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of platelet engraftment | From date of transplant to 100 days post-HSCT but prior to Part B | Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of Blood and Marrow Transplant Clinical Trials Network grade 2-3 infections | From date of transplant to 100 days post-HSCT | Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of grade ≥ II aGVHD | From date of transplant to end of study, assessed up to 2 years | Will be assessed using Mount Sinai Acute Graft Versus Host Disease International Consortium criteria. Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of cGVHD requiring systemic immunosuppressive therapy | From day +100 post-HSCT to end of study, assessed up to 2 years | Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Cumulative incidence of relapse | From date of transplant to end of study, assessed up to 2 years | Deaths in the absence of the event of interest will be considered as a competing risk. CIF estimates will be provided with 95% CIs at landmark times (e.g., day +30, day +60, day +100) for each time-to-event endpoint with a competing risk. |
| Secondary | Percentage of part A participants enrolled on part B (Feasibility) | From part A screening (day -28 to day -5 pre-transplant) to part B screening (day +35 post-HSCT to day +100 post-HSCT) assessed up to 128 days | Descriptive summaries of discrete data will present the sample size and the incidence as frequency count and percentage, with exact binomial 95% CI. |
| Secondary | Median time from transplant to part B enrollment (Feasibility) | From part A screening (day -28 to day -5 pre-transplant) to part B screening (day +35 post-HSCT to day +100 post-HSCT) assessed up to 128 days | Descriptive summaries of continuous data will present mean and standard deviation, or median, interquartile range, and range, depending on the sample distribution of the continuous variable. |
| Secondary | Patient reported quality of life outcome measurements, using the FACT-BMT patient reported outcome questionnaires | From time of part A screening to 365 days post-HSCT | Descriptive summaries of discrete data will present the sample size and the incidence as frequency count and percentage, with exact binomial 95% CI. |
| Secondary | Conversion rate of pre-transplant measurable residual disease (MRD) positive to negative | From pre-transplant MRD assessment date to 1 year on study treatment or end of therapy, whichever occurs later, assessed up to 2 years |
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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