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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Maraviroc

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