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NCT05470491 · ClinicalTrials.gov registry record · Phase 1
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 ...
A Phase 1 study of HIV and Hematologic Malignancies, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 265
- Enrollment target
- 1
- Study location
NCT05470491 is a Phase 1 study of HIV and Hematologic Malignancies that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 265 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05470491, a Phase 1 study of HIV and Hematologic Malignancies, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 265 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE allo HCT
- DRUG RIC
- DRUG GVHD prophylaxis
- DRUG Plerixafor
- DRUG Maraviroc
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2023-01-26 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05470491
The ClinicalTrials.gov registry entry for NCT05470491 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 265 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 439-participant average among 303 other HIV trials with a reported enrollment target (40% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 5 interventions - of which allo HCT is the first listed.
NCT05470491 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05470491 about?
NCT05470491 is a clinical study titled "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 ...". 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 don...
What is the current status of trial NCT05470491?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 265 participants. The study started on 2023-01-26. Estimated completion is 2027-07-30.
What conditions does trial NCT05470491 study?
This clinical trial studies the following conditions: HIV, Hematologic Malignancies.
What interventions are being tested in trial NCT05470491?
The interventions under investigation include: allo HCT (PROCEDURE), RIC (DRUG), GVHD prophylaxis (DRUG), Plerixafor (DRUG), Maraviroc (DRUG).
Who is sponsoring clinical trial NCT05470491?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05470491 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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