Clinical trial · Interventional
Phase II Maraviroc for GVHD Prevention
A Phase II Study to Assess the Efficacy of Maraviroc in Prophylaxis of GVHD in Patients With Hematologic Malignancies Undergoing Reduced-Intensity Allogeneic SCT From Unrelated Donors
NCT01785810CI-TRIAL-00049349completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maraviroc 300 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Maraviroc
- description
- Phase II, single arm, single center trial, assessing the efficacy of the combination of tacrolimus, methotrexate and maraviroc as graft-versus-host disease (GVHD) prophylaxis after unrelated donor peripheral blood stem-cell transplantation in patients with hematologic malignancies. Patients enrolled on this trial will receive a standard conditioning regimen with fludarabine and busulfan followed by a peripheral blood stem cell infusion from an unrelated donor, standard GVHD prophylaxis and standard antiviral and antifungal prophylaxis. In addition, all patients will receive maraviroc from day -3 to d+ 90.
- interventionNames
- Drug: Maraviroc 300 mg
Primary outcomes (1)
- measure
- Day +180 Rate of Grade II-IV Acute GVHD
- timeFrame
- 180 days
- description
- The cumulative incidence of grade II-IV acute GVHD by day 180 after the stem-cell infusion. This is based on consensus conference criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \<5% blasts on a bone marrow biopsy and absence of any known extramedullary disease. * Chronic myelogenous leukemia in any stage, but with documentation of \<5% blasts on a bone marrow biopsy within 6 weeks prior to transplant. * Myelodysplastic syndrome of any subtype, but with documentation of \<5% blasts on a bone marrow biopsy within 6 weeks prior to transplant. * Myeloproliferative disorders other than primary myelofibrosis. * Lymphoma - All types of lymphoma are eligible. * CLL and PLL. * Patients who meet institutional eligibility criteria for allogeneic SCT: * Renal function: Serum creatinine ≤2. * Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal. * Pulmonary disease: FVC or FEV1 ≥ 40% predicted. * Cardiac ejection fraction ≥ 40%. * Availability of an unrelated donor, identified and screened by the NMDP. The donor will have at least 7/8 HLA-A, -B, -C and -DRB1 matching by high resolution molecular typing and will meet NMDP eligibility criteria to serve as a peripheral blood stem-cell donor. * Karnofsky score ≥ 70% at the time of screening. * Capacity to understand and sign the study informed consent form. * Negative pregnancy test. Women of childbearing potential (not having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation, or be post-menopausal with a total cessation of menses of \> 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.
References
Publications (0)
Data not yet available
No reference posted for this study.