Maraviroc as GVHD Prophylaxis in Transplant Recipients

Cincinnati Children's Hospital Medical Center

Status and phase: Terminated; Phase 2; Phase 1

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

Treatments: Drug: Maraviroc

Study type: Interventional

Funder types: Other

Identifiers

NCT02167451

2014-1221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 5 to 40 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Maraviroc

Experimental group

Description:

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).

Treatment:

Drug: Maraviroc