A Phase I/II Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Transplantation Followed by GVHD Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV (PLWH)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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: 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 120
Healthy Volunteers: t
View:

• Related donor (age \>=12) deemed suitable and eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood and/or PBSC graft aliquotfor research. Related donors will be evaluated in accordance with existing institutional Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.

• Ability of participant or parent/legal guardian to understand and the willingness to sign a written informed consent document.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Jessenia C Campos, R.N.
jessenia.campos@nih.gov
(240) 858-7492
Backup
Mustafa A Hyder, M.D.
mustafa.hyder@nih.gov
(240) 858-3182
Time Frame
Start Date: 2023-01-26
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 265
Treatments
Experimental: 1/Recipient Arm 1
RIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and
Experimental: 2/Recipient Arm 2
RIC+alloHCT+GVHD prophylaxis per RP2D
No_intervention: 3/Donor Arm
Collection of research samples on hematopoietic donors
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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