OncoMatch/Clinical Trials/NCT05470491
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 ...
Is NCT05470491 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including RIC and GVHD prophylaxis for hiv.
Treatment: RIC · GVHD prophylaxis · Plerixafor · Maraviroc — 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: This study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer. Eligibility: People aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow. Design: The study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant. Participants will be screened. Their diagnoses, organ function and eligibility will be confirmed. Participants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it. Participants will be in the hospital for 6 weeks or longer. They will receive various drugs for 2 weeks to prep their body for the transplant. The transplant cells will be administered through the catheter. Participants will continue to receive drug treatments after the transplant. Blood transfusions may also be needed. Participants will return 1-2 times per week for follow-up visits for 3 months after discharge. Participants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years....
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Allowed: TP53 17p deletion
Prior therapy
Cannot have received: investigational agent
Exception: can be included if discontinued/completed at least 2 weeks prior to conditioning
Participants who are receiving any other investigational agents that cannot be discontinued/completed at least 2 weeks prior to the date of beginning conditioning
Lab requirements
Kidney function
Estimated serum creatinine clearance of >=50 mL/min/1.73m2 calculated using eGFR
Liver function
Total bilirubin <=3.0 mg/dL (unless due to Gilbert's or hemolysis), ALT and AST <= 5x ULN, GGT <= 5x ULN
Cardiac function
Cardiac ejection fraction by 2D ECHO of >=40 percent
Adequate organ function defined as possessing all of the following: Cardiac ejection fraction by 2D ECHO of >=40 percent; FEV-1, FVC, and DLco (adjusted for hemoglobin) all of >=40 percent predicted; Total bilirubin <=3.0 mg/dL (unless due to Gilbert's or hemolysis), ALT and AST <= 5x ULN, GGT <= 5x ULN; Estimated serum creatinine clearance of >=50 mL/min/1.73m2 calculated using eGFR
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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