RecruitingPhase 2NCT06532084

Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Randomized Trial of Sorafenib Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplantation Bendamustine and Cyclophosphamide


Sponsor

St. Petersburg State Pavlov Medical University

Enrollment

88 participants

Start Date

May 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether sorafenib — a targeted cancer drug — can prevent blood cancer from coming back in high-risk patients who have just received a stem cell transplant (where healthy blood stem cells from a donor are used to replace diseased ones). The transplant in this study uses a special regimen that includes bendamustine and cyclophosphamide. Researchers want to see if starting sorafenib early after transplant reduces the chance of relapse. **You may be eligible if...** - You received an allogeneic (donor) stem cell transplant using bendamustine and cyclophosphamide as part of your conditioning - You have a high-risk blood cancer like AML or MDS that met specific high-risk criteria - You are in blood cancer remission after the transplant engrafted - You are within the first 100 days after your transplant **You may NOT be eligible if...** - Your cancer relapsed and was successfully treated between transplant and enrollment - You have moderate or severe heart disease, recent heart attack, or stroke - You have severely impaired lung, liver, kidney, or other organ function - You have an active uncontrolled infection - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSorafenib

Sorafenib 200 mg bid for 168 days starting in the time fram between engraftment with neutrophils \> 1.0 x 10\^9/L, white blood cells\> 1.5 x 10\^9/L, platelets\> 1.5 x 10\^9/L and day+100 after allogeneic hematopoietic cell trnaplantation


Locations(1)

RM Gorbacheva Research Institute

Saint Petersburg, Russia

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NCT06532084


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