Trial · NCT04965597
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Graft-Versus Host-Disease (GVHD)-Free Event-Free Survival (EFS) | 1 year post-HCT | The primary endpoint is the incidence of 1-year GVHD free, EFS (GEFS). An event is defined as death due to any cause, primary or secondary graft failure/rejection, or 2nd HCT whichever occurs first. Grade III-IV acute GVHD and chronic GVHD (using National Institutes of Health \[NIH\] consensus criteria) requiring systemic immune suppression will be considered in this estimate. |
| Secondary | Overall Survival | Day 100 post-HCT | Overall survival at day 100 after HCT |
| Secondary | Overall Survival | 6 months post-HCT | Overall survival at 6 months after HCT |
| Secondary | Overall Survival | 1 year post-HCT | Overall survival at 1 year after HCT |
| Secondary | Event-Free Survival | 1 year post-HCT | Event-free survival will be estimated at 12 months after HCT. An event is defined as death due to any cause, primary or secondary graft failure/rejection, or 2nd HCT, whichever occurs first |
| Secondary | Hematologic Recovery: Neutrophil recovery | Assessed up to 1 year post-HCT | Hematologic recovery will be assessed according to neutrophil recovery after transplant. Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) ≥ to 500/mm3 for 3 consecutive measurements on 3 different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death without neutrophil recovery. |
| Secondary | Hematologic Recovery: Platelet recovery | Day 100 post-HCT | Hematologic recovery will be assessed according to platelet counts recovery after transplant. Platelet recovery is defined as the first day of a minimum of 3 days that the patient has a sustained platelet count ≥ 20,000/mm3 with no platelet transfusions in the preceding 7 days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment. |
| Secondary | Donor Chimerism (CD3 and Myeloid) | Day 28 post-HCT | Proportions of patients with full (\>95%), mixed (5-95%), or rejection (\<5%) myeloid |
| Secondary | Donor Chimerism (CD3 and Myeloid) | Day 100 post-HCT | Proportions of patients with full (\>95%), mixed (5-95%), or rejection (\<5%) myeloid |
| Secondary | Donor Chimerism (CD3 and Myeloid) | 1 year post-HCT | Proportions of patients with full (\>95%), mixed (5-95%), or rejection (\<5%) myeloid |
| Secondary | Primary graft failure/rejection | Day 42 post-HCT | Defined as never achieving ANC ≥ 500/μL or never achieving ≥ 5% donor myeloid chimerism assessed by peripheral blood chimerism assays by day +42 post-HCT. Second infusion of hematopoietic cells is also considered indicative of primary graft failure by day +42 post-HCT |
| Secondary | Secondary graft failure/rejection post-HCT | Assessed up to 1 year post-HCT | Defined as \< 5% donor myeloid chimerism in peripheral blood beyond day +42 post-HCT in patients with prior documentation of hematopoietic recovery with ≥ 5% donor cells by day +42 post-HCT. Second infusion of hematopoietic cells is also considered indicative of secondary graft failure. |
| Secondary | Grade II-IV and grade III-IV GVHD at day 100 | Day 100 post-HCT | The cumulative incidences of acute grade II-IV and III-IV GVHD at day 100 after HCT will be determined. |
| Secondary | Grade II-IV and grade III-IV GVHD at day 180 | Day 180 post-HCT | The cumulative incidences of acute grade II-IV and III-IV GVHD at day 100 after HCT will be determined. |
| Secondary | Chronic GVHD | 1 year post-HCT | The cumulative incidence of chronic GVHD (using NIH consensus criteria) requiring systemic immune suppression at 1 year after HCT will be determined. Data will be collected directly from providers and chart review as defined by the NIH Consensus Conference Criteria |
| Secondary | Incidence of grade 3-5 toxicities | Day 30 post-HCT | Grade 3-5 toxicities by day 30 after HCT |
| Secondary | Incidence of grade 3-5 toxicities | Day 100 post-HCT | Grade 3-5 toxicities by day 100 after HCT |
| Secondary | Incidence of grade 2-3 systemic infections | 6 months post-HCT | All microbiologically documented infections or significant infections requiring antibiotic/antifungal therapy occurring up to 6 months after HCT |
| Secondary | Incidence of Epstein Barr virus (EBV) reactivation requiring therapy | Day 180 post-HCT | The incidence of EBV reactivation requiring therapy in the first 180 days after HCT, and of EBV-associated lymphoproliferative disorder in the first 180 days after HCT will be evaluated. |
| Secondary | Incidence of EBV-associated lymphoproliferative disorder | Day 180 post-HCT |
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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