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OncoMatch/Clinical Trials/NCT06802315

Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)

Is NCT06802315 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cyclophosphamide (CTX) and Fludarabine (Fludara) for acute myeloid leukemia, relapsed, adult.

Phase 2RecruitingUniversity of Illinois at ChicagoNCT06802315Data as of May 2026

Treatment: Cyclophosphamide (CTX) · Fludarabine (Fludara) · Busulfan (conditioning for ALLO Transplant)The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Chronic Myeloid Leukemia

Myelodysplastic Syndrome

Biomarker criteria

Allowed: ASXL1 poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: BCOR poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: EZH2 poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: RUNX1 poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: SF3B1 poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: SRSF2 poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: STAG2 poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: U2AF1 poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: ZRSR2 poor risk molecular feature

Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: KMT2A (MLL) rearrangement (MLL rearrangement except t(9;11))

Poor-risk cytogenetics: MLL rearrangement with the exception of t(9;11)

Prior therapy

Cannot have received: radiation therapy

Exception: to >20% of bone marrow-containing areas

Patients previously received radiation to >20% of bone marrow-containing areas

Lab requirements

Kidney function

creatinine clearance <30ml/min [excluded]

Liver function

bilirubin > 2.0 mg/dl (unless due to gilbert's syndrome or hemolysis), and alt and ast > 5 x uln [excluded]

Cardiac function

left ventricular ejection fraction < 50% [excluded]

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

US trial sites

  • University of Illinois Cancer Center · Chicago, Illinois

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