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Clinical Trial Update: CTN Trial

Summarize ongoing and recently completed clinical trials related to allo-HSCT and associated therapies.

This is a video synopsis/summary of a Peer Exchange featuring Miguel-Angel Perales, MD; Nelli Bejanyan, MD; Amandeep Salhotra, MD; and Arpita Gandhi, MD, MS.

The panel discusses the use of composite end points, such as graft-vs-host disease–free, relapse-free survival (GRFS) and chronic graft-vs-host disease–free, relapse-free survival (CRFS), in a series of Blood and Marrow Transplant Clinical Trials Network (BMT CTN) trials. These end points capture the patient experience by considering survival without relapse and graft-vs-host disease (GVHD).

PROGRESS I, a randomized pick-the-winner trial, compared 3 strategies for GVHD prevention: post-transplant cyclophosphamide (PTCy), tacrolimus/methotrexate with bortezomib, and tacrolimus/methotrexate with maraviroc. PTCy emerged as the winner based on the primary end point of GRFS. PROGRESS III, published in The New England Journal of Medicine, compared PTCy with tacrolimus/methotrexate in patients with 7/8 or 8/8 HLA-matched donors, predominantly using reduced-intensity conditioning. The trial showed improved outcomes with PTCy, establishing it as a new standard of care for GVHD prevention.

PROGRESS II, a phase 3 trial, compared 3 strategies in the myeloablative setting: tacrolimus/methotrexate with bone marrow (control arm), bone marrow with PTCy alone, and CD34-selected peripheral blood stem cell graft. The trial found no difference in CRFS between the arms but showed reduced overall survival in the CD34-selected arm due to increased infections and toxicity. Subsequent efforts focused on improving CD34 selection by adjusting antithymocyte globulin dosing based on patient weight and absolute lymphocyte count.

Video synopsis is AI-generated and reviewed by OncLive® editorial staff.

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