Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

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 ID
NCT06532084
Phase
PHASE2
Sponsor
St. Petersburg State Pavlov Medical University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Sorafenib
Locations (sample)
  • Saint Petersburg, Russia|59.93863,30.31413

Key Eligibility Criteria

  • Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.
  • Patients must have high-risk myeloid malignancy as an indication for transplantation defined as:
  • acute myeloid leukemia not in hematological remission prior to transplantation,
  • ≥ 3 remission of acute myeloid leukemia,

For full eligibility, visit ClinicalTrials.gov.

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