A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation
Categories (click each to see list of all clinical trials associated with that category): BMT/GVHD (ONC), FPBCC CTO Studies, Leukemia/MDS/MPD (ONC), Lymphoma/CLL (ONC)
Current Status: Open
Phase: II
Principal Investigator: Ellithi, Moataz
Contact Information:
Stephanie Parker
steparker@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06859424?term=NCT06859424&rank=1#participation-criteria
Summary
COMMON OBJECTIVES ACROSS PLATFORM PROTOCOL
1. To assess GRFS post HCT
2. To assess GVHD-free survival (GFS) post HCT
3. To assess infection-free survival (IFS) post HCT
4. To assess overall survival post HCT
5. To assess progression-free survival (PFS) post HCT
6. To assess NRM post HCT
7. To assess the cumulative incidence of relapse and disease progression post HCT
8. To assess the cumulative incidence of neutrophil engraftment post HCT
9. To assess the cumulative incidence of platelet engraftment post HCT
10. To assess primary graft failure and secondary graft failure post HCT
11. To assess the incidence of ≥ Grade 2 infections post HCT
12. To assess donor cell engraftment post HCT
13. To assess the cumulative incidence of aGVHD post HCT
14. To assess the cumulative incidence of cGVHD post HCT
15. To assess the incidence of cytokine release syndrome (CRS) post HCT
COMMON SAFETY OBJECTIVES ACROSS PLATFORM PROTOCOL
1. To assess serious adverse events from the start of conditioning regimen through 1 year post HCT
2. To assess all adverse events (AEs) Grade 3 and higher from initiation of conditioning regimen through 1 year post HCT based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
3. To assess adverse events of special interest, (if applicable in each ISA)
COMMON EXPLORATORY OBJECTIVES ACROSS PLATFORM PROTOCOL
1. To describe the incidence of patient-reported toxicities and symptoms post HCT
2. To assess healthcare resource utilization
3. To assess the impact of cryopreservation on clinical outcomes
4. To assess the impact of social drivers of health on patient access and outcomes
5. To describe center approach to donor selection
6. To assess impact of donor HLA match grade (7/8 versus < 7/8) and donor age on selected clinical outcomes
7. To assess immune reconstitution and repertoire post-transplant
8. To assess HLA loss of heterozygosity (LOH) as a mechanism of relapse
9. To assess acute GVHD-associated biomarkers post-transplant
10. To characterize the diversity and composition of the gut microbiome post-transplant
11. To determine feasibility of centralized testing for the presence of HLA antibodies.
12. To assess the incidence of anti-HLA antibodies in patients receiving MMUD PBSCT.
13. To assess the association of anti-HLA antibodies with primary graft failure and/or poor graft function.