Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
- Conditions
- Interventions
- Registration Number
- NCT05470491
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Background:
People living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.
Objective:
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- Detailed Description
Background:
* Human Immunodeficiency Virus (HIV) infection should not be considered a barrier to hematopoietic cell transplantation (HCT) in patients who otherwise have a standard indication for HCT.
* The main historical barriers include the risk of opportunistic infections, drug interactions, and lack of donor availability.
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Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 265
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2/Recipient Arm 2 GVHD prophylaxis RIC+alloHCT+GVHD prophylaxis per RP2D 1/Recipient Arm 1 allo HCT RIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and 1/Recipient Arm 1 Plerixafor RIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and 2/Recipient Arm 2 RIC RIC+alloHCT+GVHD prophylaxis per RP2D 1/Recipient Arm 1 Maraviroc RIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and 1/Recipient Arm 1 RIC RIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and 1/Recipient Arm 1 GVHD prophylaxis RIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and 2/Recipient Arm 2 allo HCT RIC+alloHCT+GVHD prophylaxis per RP2D 2/Recipient Arm 2 Maraviroc RIC+alloHCT+GVHD prophylaxis per RP2D 2/Recipient Arm 2 Plerixafor RIC+alloHCT+GVHD prophylaxis per RP2D
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method Cumulative incidence of relapse 1, 3, and 5 years post HCT Cumulative incidence rates will be estimated based on disease-risk index.
Cumulative incidence of hematopoietic recovery day +100 cumulative incidence of hematopoietic recovery will be based on platelet recover at day +100
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
Cumulative incidence of chronic GVHD 1 and 2 years post HCT Evaluation by severity of mild, moderate, and severe
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
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
Cumulative incidence of acute GVHD Day +180 and 1 year post HCT Evaluation by all grades, grade II-IV, and grade III-IV
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
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
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States