Actively Recruiting
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 ...
Led by National Cancer Institute (NCI) · Updated on 2026-05-05
265
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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 ...
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older living with HIV
- Must have a confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation or eligible for autologous transplant consolidation if autologous transplant is not accessible
- Must have an HIV viral load under 400 copies/mL on a stable antiretroviral therapy regimen
- Must have at least one potentially suitable HLA-haploidentical related donor aged 12 or older
- Karnofsky performance score of 50% or higher
- Adequate organ function including cardiac ejection fraction of 40% or higher, lung function tests 40% or higher, and liver and kidney function within defined limits
- Ability and willingness to provide informed consent
- Individuals of childbearing potential must agree to use contraception prior to study and for one year after transplant
You will not qualify if you...
- Receiving other investigational agents that cannot be stopped at least 2 weeks before conditioning
- Poorly controlled cancer including leukemia with more than 5% blasts, lymphoma without treatment sensitivity, or multiple myeloma not in complete remission
- Uncontrolled illnesses making transplant unsafe
- Unable to suppress HIV viral load below 400 copies/mL with compatible antiretroviral therapy
- Pregnancy or unwillingness to stop breastfeeding before treatment
- Allergy to any study drugs or similar compounds
- Lack of suitable central venous access
- Active psychiatric disorders affecting compliance
- Severe motor or sensory neuropathy (grade 3-4) per CTCAE version 5.0
- Related donors who fail to qualify per institutional policies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Jessenia C Campos, R.N.
CONTACT
M
Mustafa A Hyder, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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