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)

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 65 Years
• SexAll
• Healthy volunteersNo

You may be able to join 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 cannot join 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Intensity modulated total marrow irradiation (Radiation): See "Treatment Regimen"
• Cyclophosphamide (CTX) (Drug): This study will determine the safety of the combination of Total Marrow Irradiation (TMI) and Post-Transplant Cyclophosphamide using a myeloablative fludarabine and iv targeted busulfan (Flu/Bu4) conditioning regimen.
• Fludarabine (Fludara) (Drug): chemotherapy conditioning
• Busulfan (conditioning for ALLO Transplant) (Drug): chemotherapy conditioning

Na · Single Group · masking: None

Main goals

• GVHD-Free Relapse-Free Survival after Stem Cell Transplant (1 Year Post-Stem Cell Transplant)

Other goals

• Overall Survival
• Time To Engraftment
• Adverse Events
• Adverse Events
• Adverse Events
• Adverse Events
• Adverse Events
• Incidence of Acute Graft Versus Host Disease
• Incidence of Acute Graft Versus Host Disease
• Incidence of Acute Graft Versus Host Disease
• Incidence of Acute Graft Versus Host Disease
• Incidence of Acute Graft Versus Host Disease
• Incidence of Chronic Graft Versus Host Disease
• Incidence of Chronic Graft Versus Host Disease
• Transplant-Related Mortality
• Transplant-Related Mortality
• Transplant-Related Mortality
• Transplant-Related Mortality
• Transplant-Related Mortality

Planned enrollment: 38 (estimated).

• University of Illinois Cancer Center, Chicago, Illinois

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06802315

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 25, 2026. Public record; not medical advice.