A Study of Tacrolimus/Methotrexate and Tocilizumab to Prevent Acute Graft-Versus-Host Disease (AGVD) After Allogeneic Hematopoietic Stem Cell Transplant

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
William R. Drobyski, MD
Study ID
NCT02206035
Phase
PHASE2
Status
Completed

Conditions

  • Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tacrolimus — DRUG
    Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant.
  • Methotrexate — DRUG
    Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m\^2 Days +3, +6 and +11.
  • Tocilizumab — DRUG
    Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1.

Study Details

This is a phase II open label trial designed to evaluate the efficacy of Tac/MTX/Toc in preventing graft versus host disease (GVHD). Outcomes of patients on this clinical trial will be compared to those of contemporary controls from the CIBMTR.

Key Dates

Start date
Dec 31, 2014
Status verified
Feb 2023
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Tacrolimus, Methotrexate and Tocilizumab (Tac/MTX/Toc)
    Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m2 Days +3, +6 and +11. Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1

Primary Outcome Measure

Number of Subjects Not Experiencing Grade II-IV Acute Graph Versus Host Disease (aGVHD) [ Time Frame: Day 180 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
Froedtert Hospital and the Medical College of Wisconsin· Milwaukee, WI

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