Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948753
First received: July 23, 2009
Last updated: February 6, 2013
Last verified: December 2011
  Purpose

This study investigates the effectiveness and safety of Maraviroc (an oral medication given twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day 30 after stem-cell infusion.


Condition Intervention Phase
Graft-versus-host Disease
Hematopoietic Stem Cell Transplantation
Drug: Maraviroc
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Maraviroc, a CCR5-inhibitor in Prophylaxis of Graft-Versus-Host Disease in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Efficacy and safety of Maraviroc in prevention of acute GVHD in patients undergoing non-myeloablative allogeneic SCT. [ Time Frame: Final analysis ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Explore pharmacokinetic profile of Maraviroc in patients undergoing nonmyeloablative allogeneic SCT [ Time Frame: Final analysis ] [ Designated as safety issue: Yes ]
  • Assess early mortality after transplant, rate of complications, chronic GVHD and relapse rate in patients treated with Maraviroc during SCT [ Time Frame: Final analysis ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: June 2009
Study Completion Date: January 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc + standard GVHD prophylaxis
Maraviroc 300 mg bid (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stell-cell infusion.
Drug: Maraviroc
Maraviroc 300 mg bid (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stell-cell infusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.
  • meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:

    • Renal function: Serum creatinine <2; or calculated creatinine clearance > 40 mL/min/1.72m2;
    • 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%.

Exclusion Criteria:

  • Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
  • Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
  • Patients with uncontrolled bacterial, viral or fungal infections
  • Patients who take strong inducers or inhibitors of the CYP450A4
  • Patients receiving other investigational drugs for GVHD
  • Women who are pregnant, plan to become pregnant or are breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948753

Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: David Porter, MD University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948753     History of Changes
Other Study ID Numbers: UPCC 04708
Study First Received: July 23, 2009
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Graft-versus-host disease
GVHD
Maraviroc
non-myeloablative allogeneic stem-cell transplantation
Hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on October 20, 2014