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

Abramson Cancer Center at Penn Medicine38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Graft-versus-host Disease Hematopoietic Stem Cell Transplantation

Interventions

Maraviroc 300 mg Phase IIDRUG

Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety of Maraviroc

number of Adverse Events following exposure to Maraviroc

Time frame: 1 year

Efficacy of Maraviroc

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

Time frame: 8 weeks

Secondary Outcomes

Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT

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.

Time frame: pre-dose, 1,2,3,4,6,12 hours post-dose

Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD

count of how many patients treated with Maraviroc during SCT go on to develop chronic GVHD in 1 year

Time frame: 1 year

Rate of Early Mortality After Transplant

Number of participants who died without relapse within 1 year of SCT

Time frame: 1 year

Number of Participants Who Relapsed During Study Period

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.

Time frame: 1 year and 11 months