Maraviroc as GVHD Prophylaxis in Transplant Recipients

Graft Versus Host Disease (GVHD) Clinical Trial

Official title:

Maraviroc as Graft Versus Host Disease Prophylaxis in Pediatric and Adult Stem Cell Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02167451
• Other study ID #: 2014-1221
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 2014
• Est. completion date: September 2018

Study information

• Verified date: February 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 40 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Diagnoses That Require Stem Cell Transplant
• Graft Versus Host Disease (GVHD)
• Graft vs Host Disease

Intervention

Drug:
• Maraviroc

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Maraviroc	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.	Up to day +100
Primary	GVHD Incidence	Incidence of GVHD by day+100	By day +100
Primary	Area Under The Concentration-Time Curve (AUC) of Maraviroc	pK target >100ng/ml at day zero at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration	Day 0
Primary	Incidence of Visceral GVHD	determine the number of patients who develop visceral GVHD by day+100	day+100
Primary	Area Under The Concentration-Time Curve (AUC) of Maraviroc	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	Day 10
Secondary	Overall Survival	Overall survival for patients who were enrolled and received maraviroc	By day +100
Secondary	Graft Failure	Failure to engraft and loss of graft.	By day +100
Secondary	Primary Disease Relapse		By day +100
Secondary	Toxicities	Incidence of toxicities due to drug	Up to day +100
Secondary	Infectious Complications	Infections complications which include asymptomatic viremias for EBV, Adenovirus, CMV, and/or viral disease, bacterial and fungal infections as documented by blood cultures.	Up to day +100
Secondary	Time to Neutrophil	Neutrophil engraftment is defined as the first of three consecutive measurements of ANC>500mcL over 3 or more days.	Up to day +100
Secondary	Time to Platelet Engraftment	Time to achieve platelets count of 20,000 without transfusions	days