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Maraviroc as GVHD Prophylaxis in Transplant Recipients

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ClinicalTrials.gov Identifier: NCT02167451
Recruitment Status : Terminated (slow recruitment and no further drug supply)
First Posted : June 19, 2014
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diagnoses That Require Stem Cell Transplant Graft Versus Host Disease (GVHD) Drug: Maraviroc Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Maraviroc as Graft Versus Host Disease Prophylaxis in Pediatric and Adult Stem Cell Transplant Recipients
Study Start Date : July 2014
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Maraviroc

Arm Intervention/treatment
Experimental: 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).
Drug: Maraviroc
Other Name: Selzentry




Primary Outcome Measures :
  1. Feasibility of Maraviroc [ Time Frame: 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.

  2. GVHD Incidence [ Time Frame: By day +100 ]
    Incidence of GVHD by day+100

  3. Area Under The Concentration-Time Curve (AUC) of Maraviroc [ Time Frame: Day 0 ]
    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

  4. Incidence of Visceral GVHD [ Time Frame: day+100 ]
    determine the number of patients who develop visceral GVHD by day+100

  5. Area Under The Concentration-Time Curve (AUC) of Maraviroc [ Time Frame: 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


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: By day +100 ]
    Overall survival for patients who were enrolled and received maraviroc

  2. Graft Failure [ Time Frame: By day +100 ]
    Failure to engraft and loss of graft.

  3. Primary Disease Relapse [ Time Frame: By day +100 ]
  4. Toxicities [ Time Frame: Up to day +100 ]
    Incidence of toxicities due to drug

  5. Infectious Complications [ Time Frame: 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.

  6. Time to Neutrophil [ Time Frame: Up to day +100 ]
    Neutrophil engraftment is defined as the first of three consecutive measurements of ANC>500mcL over 3 or more days.

  7. Time to Platelet Engraftment [ Time Frame: days ]
    Time to achieve platelets count of 20,000 without transfusions



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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167451


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Pooja Khandelwal, MD Children's Hospital Medical Center, Cincinnati
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02167451    
Other Study ID Numbers: 2014-1221
First Posted: June 19, 2014    Key Record Dates
Results First Posted: March 10, 2020
Last Update Posted: March 10, 2020
Last Verified: February 2020
Keywords provided by Children's Hospital Medical Center, Cincinnati:
stem cell transplant
GVHD prevention
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Maraviroc
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
CCR5 Receptor Antagonists