OncoMatch

OncoMatch/Clinical Trials/NCT06477549

BeFluBu vs FluBuRux Conditioning in Haploidentical HCT

Is NCT06477549 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bendamustine Hydrochloride and Ruxolitinib for acute lymphoblastic leukemia.

Phase 2RecruitingSt. Petersburg State Pavlov Medical UniversityNCT06477549Data as of May 2026

Treatment: Bendamustine Hydrochloride · RuxolitinibHaploidentical hematopoietic stem cell transplantation irrespective of the conditioning intensity and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 7-20% of graft failures in different diseases. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of diseases. In two previously completed trials of addition of either bendamustine and ruxolitinib to conditioning we observed low rates of primary graft failure with both approaches. The study is the direct randomized comparisons of these two approaches with the primary aim of reducing composite events of primary graft failure, relapse and non-relapse mortality. The stratas for the study are Disease Risk Index (DRI) and the age of the haploidentical donor (\<35 vs ≥35).

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Non-Hodgkin Lymphoma

Myeloproliferative Neoplasm

Myelodysplastic Syndrome

Lab requirements

Kidney function

creatinine ≤2 upper normal limits, creatinine clearance ≥40 mL/min

Liver function

AST or ALT ≤5 upper normal limits, bilirubin ≤1.5 upper normal limits

Cardiac function

ejection fraction ≥50%, no unstable angina, no stable angina NYHA class III or IV, no chronic heart failure NYHA class III or IV, no Lawn grade V arrhythmia, no myocardial infarction within 3 months

Moderate or severe cardiac disease: 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; Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits; Creatinine clearance < 40 mL/min

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

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