Clinical Trial

Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Study acronym: SoraGVL
Recruiting Phase 2
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Summary
This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.
Trial Details
NCT Number NCT06532084
Lead Sponsor St. Petersburg State Pavlov Medical University
Conditions Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndromes, Chronic Myeloid Leukemia, Myeloproliferative Neoplasm
Enrollment 88 participants
Start Date 2024-05-22
Primary Completion 2027-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2024-08-01