Maraviroc as GVHD Prophylaxis in Transplant Recipients

Phase 1

Terminated

• Conditions: Diagnoses That Require Stem Cell Transplant; Graft Versus Host Disease (GVHD)
• Interventions: Drug: Maraviroc

• Registration Number: NCT02167451
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

The purpose is to determine if the addition of Maraviroc to a standard transplant regimen will reduce the incidence of graft versus host disease in children and young adults after a stem cell transplant.

Detailed Description

In the first stage, drug levels will be obtained to establish appropriate dosing. In the second stage of the study the investigators will study the effects of using Maraviroc in these patients.

Study Timeline

• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-19
• Study Start: 2014-07
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Results First Submitted: 2019-09-12
• Status Verified: 2020-02
• Results First Submitted QC: 2020-03-02
• Last Update Submitted: 2020-03-02
• Results First Posted: 2020-03-10
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Ages 5 years and </= 40 years
• All diagnoses
• Peripheral blood stem cells, marrow or cord blood
• All conditioning regimens
• Patient must be planned to receive a calcineurin inhibitor (cyclosporine or tacrolimus) together with steroid, methotrexate or mycophenolate mofetil as GVHD prophylaxis.

Exclusion Criteria

• Documented anaphylaxis to Maraviroc
• Ex vivo T-cell (type of white blood cell) depleted grafts
• Abnormal Alanine Aminotransferase (ALT) (>/=10X ULN) on day -3. (Assessed at study enrollment and confirmed again prior to the first dose of maraviroc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maraviroc	Maraviroc	Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).

Primary Outcome Measures

Name	Time	Method
Area Under The Concentration-Time Curve (AUC) of Maraviroc	Day 10	pK target \>100ng/ml at day 10 at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration
Incidence of Visceral GVHD	day+100	determine the number of patients who develop visceral GVHD by day+100
Feasibility of Maraviroc	Up to day +100	The ability to administer twice daily oral maraviroc in children and adults undergoing stem cell transplant in addition to routine standard graft versus host disease prophylaxis.
GVHD Incidence	By day +100	Incidence of GVHD by day+100

Secondary Outcome Measures

Name	Time	Method
Overall Survival	By day +100	Overall survival for patients who were enrolled and received maraviroc
Graft Failure	By day +100	Failure to engraft and loss of graft.
Primary Disease Relapse	By day +100
Toxicities	Up to day +100	Incidence of toxicities due to drug
Infectious Complications	Up to day +100	Infections complications which include asymptomatic viremias for EBV, Adenovirus, CMV, and/or viral disease, bacterial and fungal infections as documented by blood cultures.
Time to Neutrophil	Up to day +100	Neutrophil engraftment is defined as the first of three consecutive measurements of ANC\>500mcL over 3 or more days.
Time to Platelet Engraftment	days	Time to achieve platelets count of 20,000 without transfusions

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States