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A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)

NCT04934670 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-08-27

Study results available
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Summary

This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.

Conditions

  • Steroid-Refractory Acute Graft Versus Host Disease

Interventions

DRUG

T-Guard

T-Guard will be administered intravenously inpatient over 4 hours every 2 calendar days on Days 0, 2, 4, and 6, at a dose of 4mg/m2 Body Surface Area (BSA).

DRUG

Ruxolitinib

Ruxolitinib will be administered orally twice a day starting on Day 0 through Day 56, at a dose of 10mg. Ruxolitinib taper can be initiated starting on Day 56 for participants responding to treatment, tapering will be done according to institutional practices.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Blood and Marrow Transplant Clinical Trials Network

    collaborator NETWORK

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Marrow Donor Program

    collaborator OTHER

  • Xenikos

    lead INDUSTRY

Principal Investigators

  • Mary Horowitz, MD, MS · Center for International Blood and Marrow Transplant Research

  • Willem Klaasen · Xenikos, BV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2022-11-10
Completion
2023-01-19
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Croatia
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

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 NCT04934670 on ClinicalTrials.gov