OncoMatch/Clinical Trials/NCT06532084

Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Is NCT06532084 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sorafenib for acute myeloid leukemia, in relapse.

Phase 2RecruitingSt. Petersburg State Pavlov Medical UniversityNCT06532084Data as of May 2026

Treatment: Sorafenib — 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Chronic Myeloid Leukemia

Myeloproliferative Neoplasm

Biomarker criteria

Required: TP53 bi-allelic mutation

any myeloid malignancy with bi-allelic tp53 mutation

Required: TP53 bi-allelic mutation

any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression

Required: ASXL1 mutation

any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression

Required: RUNX1 mutation

any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression

Required: MECOM overexpression

any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression

Prior therapy

Must have received: allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide (bendamustine, cyclophosphamide) — post-transplant

Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.

Cannot have received: donor lymphocyte infusion

donor lymphocyte infusion prior to randomization

Cannot have received: any other planned method for prophylaxis of relapse besides sorafenib

use of any other planned method for prophylaxis of relapse besides sorafenib

Lab requirements

Kidney function

creatinine >2 upper normal limits, creatinine clearance < 30 ml/min

Liver function

ast or alt >10 upper normal limits, bilirubin >2 upper normal limits

Cardiac function

ejection fraction <50%, unstable angina, stable angina nyha class iii or iv, chronic heart failure nyha class iii or iv, lawn grade v arrhythmia, myocardial infarction within 3 months before inclusion

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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