NCT02167451

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

February 1, 2020

Enrollment Period

4.2 years

First QC Date

June 13, 2014

Results QC Date

September 12, 2019

Last Update Submit

March 2, 2020

Conditions

Diagnoses That Require Stem Cell TransplantGraft Versus Host Disease (GVHD)

Keywords

stem cell transplantGVHD prevention

Outcome Measures

Primary Outcomes (5)

  • 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

  • GVHD Incidence

    Incidence of GVHD by day+100

    By day +100

  • 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

  • Incidence of Visceral GVHD

    determine the number of patients who develop visceral GVHD by day+100

    day+100

  • 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 Outcomes (7)

  • Overall Survival

    By day +100

  • Graft Failure

    By day +100

  • Primary Disease Relapse

    By day +100

  • Toxicities

    Up to day +100

  • Infectious Complications

    Up to day +100

  • +2 more secondary outcomes

Study Arms (1)

Maraviroc

EXPERIMENTAL

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

Interventions

MaravirocDRUG
Also known as: Selzentry
Maraviroc

Eligibility Criteria

Age5 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

early termination leading to small number of subjects analyzed.

Results Point of Contact

Title
Pooja Khandelwal, MD
Organization
Cincinnati Children's Hospital Medical Center
Pooja.Khandelwal@cchmc.org
513-803-4762

Study Officials

  • Pooja Khandelwal, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 19, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

March 10, 2020

Results First Posted

March 10, 2020

Record last verified: 2020-02

Locations

US(1)