A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Bhatt, Vijaya; Ellithi, Moataz
Contact Information:
Vijaya Bhatt, MD
402-559-5163
vijaya.bhatt@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06799195?term=NCT06799195&rank=1#participation-criteria
Summary
Primary Objectives
1. To compare health-related quality of life at three months post allogeneic hematopoietic stem cell transplant (HCT) between recipients receiving attenuated versus high dose of post-transplant cyclophosphamide (PTCy) in addition to two drug graft-versus-host disease (GVHD) prophylaxis.
Secondary Objectives
1. To compare functional outcomes at three months post-HCT in recipients of attenuated versus high dose of PTCy in addition to two-drug GVHD prophylaxis.
2. To compare Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) at one year post-HCT among the two treatment arms. An event for this time-to-event outcome is defined as grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause.
3. To compare overall survival (OS) and event-free survival (EFS) at one year post-HCT among the two treatment arms.
4. To determine the cumulative incidence of disease relapse and transplant-related mortality (TRM) at one year among the two treatment arms.
5. To determine the cumulative incidence of grade II-IV acute GVHD at one year among the two treatment arms, according to the Mount Sinai acute GVHD grading system.
6. To determine the cumulative incidence of chronic GVHD of different grades at one year among the two treatment arms, according to the NIH chronic GVHD grading system.
7. To determine the cumulative incidence and kinetics of hematologic recovery (neutrophil and platelet) among the two treatment arms.
8. To determine the incidence of adverse events grade III or higher among the two treatment arms, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
9. To determine the cumulative incidence of grade II or higher infections at 6 months among the two treatment arms per the BMT CTN criteria.