New hope for HIV patients with blood cancer: safer bone marrow transplants on the horizon?
NCT ID NCT05470491
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 22 times
Summary
This study tests whether a combination of three drugs (cyclophosphamide, bortezomib, and maraviroc) can safely prevent graft-versus-host disease after a half-matched bone marrow transplant in people living with HIV who also have a blood cancer. The trial involves 265 participants and has two phases: first to check safety, then to see if the drug combo works better than standard care. Participants will be hospitalized for about 6 weeks and followed for up to 5 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cyclophosphamide, bortezomib, and maraviroc
- What this could lead to
- If successful, this could offer a safer way to perform bone marrow transplants in people with HIV, potentially improving cancer control and survival.
- What could go wrong
- This is an early-phase trial (Phase I/II) with a small number of participants, so the new drug combo may not prove safer or more effective than standard care. There are also risks of serious side effects like graft-versus-host disease and infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 265 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA - RECIPIENT: * Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following: * Acute myeloid leukemia in morphologic complete remission (\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease) * Any secondary and/or treatment related myeloid neoplasm with antecedent history of myeloid neoplasm or previous chemotherapy/radiation * B-cell acute lymphoblastic leukemia in first or subsequent complete remission * T-cell acute lymphoblastic leukemia in first or subsequent complete remission * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R) * Primary myelofibrosis of intermediate-2 or higher risk by the Dynamic IPSS-Plus (DIPSS-Plus) or high to very high risk score (5 or higher) calculated with MIPSS70+ Calculator; DIPSS-Plus For Myeloproliferative Neoplasms on the Mutation Enhanced International Prognostic Score System (MIPSS70/MIPSS70+) * Chronic myelomonocytic leukemia * Chronic myelogenous leukemia resistant to or intolerant of \>=3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis * B-cell lymphoma including Hodgkin lymphoma that has relapsed/progressed within 1 year of completion of primary treatment, after autologous transplantation or has progressed through at least 2 lines of therapy * Burkitt or lymphoblastic lymphoma: high-risk disease in first remission, progression/relapse after \>=1 previous regimen * Chronic lymphocytic leukemia with 17p deletion and/or unmutated IgHv or refractory or intolerant of both BTK and PI3K inhibitors * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on published clinical practice guidelines * T-Prolymphocytic leukemia progressing/relapsing after alemtuzumab and at least one other regimen * B-Prolymphocytic leukemia progressing/relapsing after fludarabine and at least one other salvage regimen * Hematologic malignancy of dendritic cell or histiocytic cell type * Multiple myeloma that relapses after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD), relapses after autologous transplantation, or manifests as plasma cell leukemia In addition to standard indications for HCT: Participant with a hematologic malignancy eligible for consolidation of first remission with autologous transplantation, if autologous transplantation is not accessible to the participant. * HIV seropositive, with ART regimen that, when stable for \>4 weeks, is associated with an HIV viral load \<400 copies/mL at screening evaluations. Subsequent changes to avoid/optimize drug interactions with study drugs or essential supportive care drugs may be made to the ART regimen at any time during the eligibility assessment period, as long as the eligibility criteria were met and the regimen change is expected, by the study team and involved consultants/pharmacy, to be similarly effective for HIV control. These changes to the ART regimen are not part of the study. If changes to the ART regimen are made during the eligibility period, HIV viral load will be rechecked at least 1 week after the change but prior to protocol treatment consent. * Dose level 1: ART regimen must include maraviroc * Dose level 2 and 3: ART regimen must not include maraviroc and there must be no history of maraviroc intolerance or resistance * Age \>= 18 years * At least one potentially suitable HLA-haploidentical first degree or collateral related donor. Recipients with donor-specific anti-HLA antibodies (DSAs) to all potential donors must have at least one potential donor option where the DSA strength has a mean fluorescence intensity of \< 5000 and antibodies are not complement-fixing. * Karnofsky performance score \>=50 percent. * Adequate organ function defined as possessing all of the following: * Cardiac ejection fraction by 2D ECHO of \>=40 percent * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLco, adjusted for hemoglobin) all of \>=40 percent predicted. If unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation \>92 percent on room air. * Total bilirubin \<=3.0 mg/dL (unless due to Gilbert's or hemolysis), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \<= 5x the upper limit of normal, gamma glutamyl transferase (GGT) \<= 5x the upper limit of normal * Estimated serum creatinine clearance of \>=50 mL/min/1.73m2 calculated using eGFR in the clinical lab * Ability of participant to understand and the willingness to sign a written informed consent document. * Individuals of childbearing potential and those that can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-allo HCT. EXCLUSION CRITERIA - RECIPIENT: * Participants who are receiving any other investigational agents that cannot be discontinued/completed at least 2 weeks prior to the date of beginning conditioning. * Poorly controlled malignant indication for transplantation, defined as: * Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \>5 percent or active extramedullary disease) * Lymphoma not having demonstrated some degree of treatment sensitivity (chemosensitivity, radiosensitivity) by clinical and/or radiologic assessment * Multiple myeloma not in complete remission, as determined by negative immunofixation in serum and urine and disappearance of any soft tissue plasmacytomas and \<= 5 percent plasma cells in the bone marrow. * Uncontrolled intercurrent illness that in the opinion of the PI would make it unsafe to proceed with transplantation. * Study team is unable to identify an adequate antiretroviral regimen to adequately suppress the HIV viral load \<400 copies/mL that is compatible with study drugs * Pregnancy * For lactating potential participants: unwilling to discontinue lactation prior to the start of study treatment on day -14. * Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (eATG, steroids, cyclophosphamide, busulfan, pentostatin, maraviroc, bortezomib, plerixafor (dose level 3 only)) used in the study. * Lack of central access potential sufficient for transplant * Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol and/or antiretroviral therapy * Grade 3-4 motor or sensory neuropathy per CTCAE version 5.0 INCLUSION CRITERIA - RELATED DONOR: * 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. EXCLUSION CRITERIA - RELATED DONOR: -Failure to qualify per institutional Standard Policies
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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