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

Phase 1

Completed

• Conditions: Graft-versus-host Disease; Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Maraviroc 150 MG; Drug: Maraviroc 300 mg Phase II; Drug: Maraviroc 300 mg

• Registration Number: NCT00948753
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Disposition First Submitted: 2020-04-16
• Disposition First Submitted QC: 2020-04-16
• Disposition First Posted: 2020-04-22
• Results First Submitted: 2021-09-14
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-25
• Last Update Submitted: 2022-04-25
• Results First Posted: 2022-05-17
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1: 150mg Maraviroc	Maraviroc 150 MG	150mg twice daily
Phase 2: 300mg Maraviroc	Maraviroc 300 mg Phase II	300mg twice daily
Phase 1: 300mg Maraviroc	Maraviroc 300 mg	300mg twice daily

Primary Outcome Measures

Name	Time	Method
Safety of Maraviroc	1 year	number of Adverse Events following exposure to Maraviroc
Efficacy of Maraviroc	8 weeks	Efficacy is measured by number of participants progressing to acute GVHD. If acute GVHD is noted in a participant following exposure to study drug, then efficacy was not achieved.; If no GVHD was noted following exposure, then efficacy was achieved in that participant

Secondary Outcome Measures

Name	Time	Method
Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD	1 year	count of how many patients treated with Maraviroc during SCT go on to develop chronic GVHD in 1 year
Number of Participants Who Relapsed During Study Period	1 year and 11 months	Number of participants who received Maraviroc during SCT who relapsed within 1 year and 11 months. This was based on a diagnosis made by their physician that their primary cancer had returned.
Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT	pre-dose, 1,2,3,4,6,12 hours post-dose	Plasma maraviroc levels were measured in the blood with a target level of 100 ng per milliliter. Blood was drawn on Day 0 and Day 10-12 at pre-dose, 1, 2, 3, 4, 6, and 12 hours post-dose. Data was analyzed looking at the number of patients to achieve the target of 100 ng per milliliter at any time point.
Rate of Early Mortality After Transplant	1 year	Number of participants who died without relapse within 1 year of SCT