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Phase II Maraviroc for GVHD Prevention

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ClinicalTrials.gov Identifier: NCT01785810
Recruitment Status : Active, not recruiting
First Posted : February 7, 2013
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Requiring Allogeneic Stem-cell Transplantation. Drug: Maraviroc 300 mg Phase 2

Detailed Description:

Detailed Description:


To estimate the cumulative incidence of grade 2-4 acute GVHD by day 180 with the addition of maraviroc to a standard prophylaxis regimen in patients with hematologic malignancies undergoing reduced intensity allogeneic stem-cell transplantation (RIC SCT) from unrelated donors.


  1. To assess the toxicity of a prolonged administration of maraviroc in patients undergoing RIC SCT.
  2. To estimate the rates of severe (grade 3-4) acute GVHD by day 100 and 180, grade 2-4 acute GVHD by day 100, organ-specific acute GVHD, chronic GVHD, relapse, infections, non-relapse mortality, use of immunosuppressive therapies and 1-year survival in patients treated with maraviroc after RIC SCT.
  3. To assess the effect of treatment with maraviroc on immune recovery, engraftment and donor T-cell chimerism in peripheral blood and in target organs.
  4. To assess the effect of donor and recipient CCR5 genotype on the incidence of acute GVHD in patients receiving maraviroc as part of a GVHD prophylaxis regimen.

OUTLINE: Patients 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 receive maraviroc from day -3 to d+ 90.

Patients are followed for 1 year after the stem-cell infusion.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Primary Purpose: Treatment
Official Title: A Phase II Study to Assess the Efficacy of Maraviroc, a CCR5-Antagonist in Prophylaxis of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Undergoing Reduced-Intensity Allogeneic Stem-Cell Transplantation From Unrelated Donors
Study Start Date : February 2013
Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Maraviroc
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single Arm Drug: Maraviroc 300 mg

Outcome Measures

Primary Outcome Measures :
  1. Number of Serious Adverse Events [ Time Frame: 180 days ]
    The cumulative incidence of grade 2-4 acute GVHD by day 180 after the stem-cell infusion

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785810

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Principal Investigator: David Porter, MD Abramson Cancer Center of the University of Pennsylvania
More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01785810     History of Changes
Other Study ID Numbers: UPCC 04712
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents