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

NCT02206035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-03-09

Study results available
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Summary

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.

Conditions

  • Hematopoietic Stem Cell Transplantation

Interventions

DRUG

Tacrolimus

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.

DRUG

Methotrexate

Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m\^2 Days +3, +6 and +11.

DRUG

Tocilizumab

Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1.

Sponsors & Collaborators

  • William R. Drobyski, MD

    lead OTHER

Principal Investigators

  • William Drobyski, MD · Medical College of Wisconsin

  • Marcelo Pasquini, MD · Medical College of Wisconsin

  • Jennifer Knight, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02206035 on ClinicalTrials.gov