Trial comparing treatments for HIV
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 ...
ClinicalTrials.gov ID: NCT05470491
What this study is testing
What is RIC?
An investigational drug regimen being studied to prevent graft‑versus‑host disease after bone marrow transplant in people living with HIV. It is designed to suppress the immune system before transplant.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the drugs cyclophosphamide, maraviroc, and bortezomib are safe and can reduce graft‑versus‑host disease (GVHD) after transplant, and to observe the transplant’s effect on survival and cancer control.
- Who it's for
- Adults 18 or older who have HIV and a blood cancer that can be treated with a bone marrow transplant.
- What's involved
- Participants will have a catheter placed for medication and blood draws, receive a transplant and the drug combination, and stay in the hospital for at least six weeks. After discharge, they will have follow‑up visits 1–2 times per week for three months, then at 6, 12, 18, 24 months and yearly for five years.
- Time commitment
- The study lasts about 5 years, with hospital stays of at least six weeks and regular follow‑up visits as described.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 120. Healthy volunteers may be eligible.
You may be able to join if
- Acute myeloid leukemia in morphologic complete remission (\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no...
- 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)
You likely can't join if
- Participants who are receiving any other investigational agents that cannot be discontinued/completed at least 2 weeks prior to the date of beginning...
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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
- 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...
- HIV seropositive, with ART regimen that, when stable for \>4 weeks, is associated with an HIV viral load \<400 copies/mL at screening evaluations.
- 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...
- Karnofsky performance score \>=50 percent.
- 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.
- 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...
- 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
What rules you out
- Participants who are receiving any other investigational agents that cannot be discontinued/completed at least 2 weeks prior to the date of beginning conditioning.
- 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...
- 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
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 120 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.