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T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)

NCT04128319 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-12-16

Study results available
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Summary

The study is designed as an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD).

Conditions

  • Steroid-Refractory Acute Graft Versus Host Disease

Interventions

DRUG

T-Guard

Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).

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

  • Mehdi Hamadani, MD · Medical College of Wisconsin

  • John Levine, MD · Icahn School of Medicine at Mount Sinai

  • Gabrielle Meyers, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-21
Primary Completion
2020-02-17
Completion
2020-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04128319 on ClinicalTrials.gov