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)

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia, Relapsed, Adult, Acute Myeloid Leukemia Refractory, Chronic Myeloid Leukemia - Accelerated Phase, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID: NCT06802315
Run by: University of Illinois at Chicago
People needed: 38
Starts: 2025-02-04
Expected to finish: 2032-03-01
Last updated by the study team: 2026-06-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

1. Age 18-65 years.
2. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as <5% bone marrow blasts morphologically:
AML arising from MDS, a myeloproliferative disorder, or secondary AML
Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features:
Poor-risk cytogenetics including 3q abnormalities, 7/7q minus or complex cytogenetics (>3 abnormalities).
Current or previous INT-2 or high IPSS score.
Treatment-related MDS.
MDS diagnosed before the age of 21 years.
Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy.
Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase.

You may not qualify if…

1. Presence of significant co-morbidity as shown by:
1a. Left ventricular ejection fraction < 50%
2b. Creatinine clearance <30ml/min.
3c. Bilirubin > 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST > 5 x ULN.
4d. FEV1 and FVC < 50% of predicted or DLCO <50% of predicted once corrected for anemia.
5e. Karnofsky score <70
6f. Active viral hepatitis or HIV infection.
7g. Cirrhosis.
2. Pregnancy or breast feeding
3. Patients unable to sign informed consent.
4. Patients previously received radiation to >20% of bone marrow-containing areas.

Where it is running

University of Illinois Cancer Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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