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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 (Jun 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 Jun 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

Treatments studied

Chemotherapy

Cyclophosphamide (CTX)

Other

Fludarabine (Fludara)Busulfan (conditioning for ALLO Transplant)

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)

Demographics

Ages ≤ 65

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

Showing up to 5 US sites.

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Frequently asked questions

Is NCT06802315 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiation therapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 65 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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