Trial · NCT05470491
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | In phase II, avoidance rate of grade III-IV acute GVHD at day +100 | day +100 post HCT | Proportion of evaluable recipients who experience grade III-IV acute GVHD at day +100 will be reported along with 80% and 95% two-sided confidence interval |
| Primary | Determine a safe and recommended phase II dose level regimen | day +100 post HCT | Number and type of toxicities noted for participants who are evaluable |
| Secondary | Cumulative incidence of primary and secondary graft failure | day +100 and 1 year post HCT | Cumulative incidence of primary and secondary graft failure based on chimerism at day +100 and 1 year post transplant |
| Secondary | Cumulative incidence of hematopoietic recovery | day +100 | cumulative incidence of hematopoietic recovery will be based on platelet recover at day +100 |
| Secondary | Overall Survival | 1, 2, 3, 4, and 5 years post HCT | Time from transplant to death of any cause and will be determined using the Kaplan-Meier method |
| Secondary | Cumulative incidence of relapse | 1, 3, and 5 years post HCT | Cumulative incidence rates will be estimated based on disease-risk index. |
| Secondary | GVHD-free, relapse free survival (GRFS) | 1, 3, and 5 years post HCT | Time from transplant to death from any cause of other event and will be determined using the Kaplan-Meier method |
| Secondary | Cumulative incidence of acute GVHD | Day +180 and 1 year post HCT | Evaluation by all grades, grade II-IV, and grade III-IV |
| Secondary | Cumulative incidence of chronic GVHD | 1 and 2 years post HCT | Evaluation by severity of mild, moderate, and severe |
| Secondary | Progression Free Survival (PFS) | 1, 3, and 5 years post HCT | Time from transplant to disease progression and will be determined using the Kaplan-Meier method |
| Secondary | Cumulative incidence of transplant-related mortality (TRM) | day +100, 1 year, and 2 years post HCT | cumulative incidence of transplant related mortality will be estimated |
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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GET https://conductscience.org/api/trials/v1/NCT05470491/registered