Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Recruiting Phase 2 Interventional Study
Acute Myeloid Leukemia, in Relapse Myelodysplastic Syndromes Chronic Myeloid Leukemia Myeloproliferative Neoplasm
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
88 (estimated)
Sponsor
St. Petersburg State Pavlov Medical University · Other
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About This Trial

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 Locations

Sorted by distance from Montana

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Eligibility Criteria
Inclusion 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 n…
Contacts

IVAN S MOISEEV

+78123386265

moisiv@mail.ru

CONTACT

Irina V Bykova

+78123386617

bmt-director@1spbgmu.ru

CONTACT