Phase 2
N=37
Phase II Maraviroc for GVHD Prevention
Hematologic Malignancy
Bottom Line
View on ClinicalTrials.gov: NCT01785810 ↗Enrolled (actual)
37
Serious AEs
13.5%
Results posted
Jan 2021
Primary outcome: Primary: Day +180 Rate of Grade II-IV Acute GVHD — 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Maraviroc 300 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Day +180 Rate of Grade II-IV Acute GVHD |
22 | — |
Summary
RATIONALE: Successful allogeneic stem-cell transplantation is often limited by graft-versus-host disease (GVHD). Migration of donor cells into tissues plays a major role in GVHD. Drugs that block chemokine receptors such as CCR5, can potentially decrease the migration of donor cells into tissues. Blocking CCR5 after allogeneic stem-cell transplantation may therefore reduce the rates of GVHD.
PURPOSE: This study explores the efficacy of pharmacologic inhibition of CCR5 in prevention of GVHDby administering maraviroc during allogeneic stem-cell transplantation with reduced intensity conditioning.
Eligibility Criteria
Inclusion Criteria
- Patients ≥18 years of age with a hematologic malignancy other than aplastic anemia or primary myelofibrosis, scheduled to undergo RIC allogeneic SCT with a peripheral blood stem cell graft from an unrelated donor, using Flu/Bu conditioning and Tac/MTX GVHD prophylaxis. The following diagnoses are included:
- Acute leukemia - AML, ALL or acute biphenotypic leukemia. Patients will have documentation of complete remission within 6 weeks prior to their transplant. Complete remission is defined as 1 year) must agree to use documented reliable method(s) of contraception. Men should agree to use condoms during the study period.
- Co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed.
Exclusion Criteria
- Patients with aplastic anemia or primary myelofibrosis. Patients with marrow fibrosis secondary to MDS, AML or a myeloproliferative disorder other than primary myelofibrosis are eligible.
- Patients who are not expected to be available for follow-up in our institution for at least 180 days after the transplant.
- Prior allogeneic SCT.
- Uncontrolled bacterial, viral or fungal infections.
- Patients who receive maraviroc for the treatment of HIV infection.
- Patients receiving other investigational drugs for GVHD.
- Co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed.
- Patients with prior malignancies are excluded unless treated with curative intent and known to be free of disease for at least 2 years.
Data sourced from ClinicalTrials.gov (NCT01785810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.