RecruitingAcute Myeloid Leukemia, Relapsed, AdultAcute Myeloid Leukemia RefractoryChronic Myeloid Leukemia - Accelerated Phase
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)
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Illinois at Chicago
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.
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.
Where it's recruiting
Illinois
Chicago
Source: ClinicalTrials.gov · NCT06802315 · last updated 2026-06-26