Phase II Maraviroc for GVHD Prevention

Completed · Phase 2

Conditions studied: Hematologic Malignancy

In brief

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.

Key facts

Study ID

NCT01785810

Run by

Abramson Cancer Center at Penn Medicine

People needed

37

Starts

2013-02-01

Expected to finish

2018-07-12

Last updated by the study team

2021-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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