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

Abramson Cancer Center at Penn Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Graft-versus-host Disease; Hematopoietic Stem Cell Transplantation

Treatments: Drug: Maraviroc 300 mg; Drug: Maraviroc 150 MG; Drug: Maraviroc 300 mg Phase II

Study type: Interventional

Funder types: Other

Identifiers

NCT00948753

UPCC 04708

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

Phase 1: 150mg Maraviroc

Experimental group

Description:

150mg twice daily

Treatment:

Drug: Maraviroc 150 MG

Phase 1: 300mg Maraviroc

Experimental group

Description:

300mg twice daily

Treatment:

Drug: Maraviroc 300 mg

Phase 2: 300mg Maraviroc

Experimental group

Description:

300mg twice daily

Treatment:

Drug: Maraviroc 300 mg Phase II