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

Conditions

• Steroid-Refractory Acute Graft Versus Host Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• T-Guard — DRUG
  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).
• Ruxolitinib — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jun 16, 2022

Status verified

Apr 2022

Primary completion

Nov 10, 2022

Completion

Jan 19, 2023

Study Design

Enrollment

12 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: T-Guard
  Participants will be administered four doses of T-Guard intravenously for a 4-hour period every other day
• Active Comparator: Ruxolitinib
  Participants will take ruxolitinib twice daily for continuous daily dosing

Primary Outcome Measure

Complete Response (CR) [ Time Frame: Day 28 ]

Locations (12)

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