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Novel GVHD Prophylaxis Approaches vs Contemporary Controls (BMT CTN 1203)

NCT02208037Phase 2

Key facts

Status: Completed
Start: Aug 2014
Primary completion: Oct 2017
Countries: 1
Sponsor: National Heart, Lung, and Blood Institute
Modality: Small Molecules, Modified Peptides

Drugs: bortezomibmaraviroccyclophosphamide
Conditions: graft-versus-host disease (GVHD)

Overview

Phase 2, randomised, open-label trial in graft-versus-host disease (GVHD) comparing Tac/MTX/Bortezomib, Tac/MTX/Maraviroc and Tac/MMF/Cyclophosphamide (3 arms). Primary endpoint: GVHD-free, Relapse-free Survival at 1 year. Started Aug 2014; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Tac/MTX/Bortezomib
Tacrolimus, Methotrexate, and Bortezomib
Tac/MTX/Maraviroc
Tacrolimus, Methotrexate, and Maraviroc
Tac/MMF/Cyclophosphamide
Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide

Who it enrols

Adult patients (18-75) with acute leukemia, CML, MDS, CLL, or lymphoma eligible for reduced intensity conditioning allogeneic HSCT with a matched related or unrelated donor. Patients must have adequate organ function and no active infection or HIV.

Endpoints

Primary

GVHD-free, Relapse-free Survival1 year

Secondary

Grade II-IV Acute Graft-versus-Host Disease180 days
Grade III-IV Acute Graft-versus-Host Disease180 days
Chronic Graft-versus-Host Disease1 year
Chronic GVHD Requiring Immunosuppressive Therapy1 year
Disease Relapse or Progression1 year
Transplant-Related Mortality1 year
Disease-free Survival1 year
Overall Survival1 year

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