CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Tacrolimus +2 moredrug
Likely dose
Methotrexate 15 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02206035
NCT02206035Phase 2Completed
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Phase II Open-Label Trial of Tacrolimus/Methotrexate and Tocilizumab for the Prevention of Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

William R. Drobyski, MD·interventional·Posted Aug 1, 2014·Updated Mar 9, 2023

In Brief

A Phase 2 clinical trial evaluating Tacrolimus, Methotrexate, and 1 other intervention for Hematopoietic Stem Cell Transplantation. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematopoietic Stem Cell Transplantation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 1, 2014
Enrollment StartDec 1, 2014
Primary CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.9 years ago

Interventions

Tacrolimusdrug

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.

Methotrexatedrug

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

Tocilizumabdrug

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