Actively Recruiting
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)
Led by University of Illinois at Chicago · Updated on 2025-06-25
38
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of CML, AML, or MDS with one of the following: relapsed or refractory AML including AML in second remission
- Poor-risk AML in first remission defined by less than 5% bone marrow blasts
- AML arising from MDS, myeloproliferative disorder, or secondary AML
- Poor-risk molecular features as defined by specific genetic markers
- Poor-risk cytogenetics including monosomal or complex karyotype and specific chromosome abnormalities
- Primary refractory disease
- MDS with poor-risk cytogenetics, high IPSS score, treatment-related MDS, early diagnosis before age 21, resistance to standard therapy, or life-threatening cytopenias
- CML with history of accelerated or blast phase
You will not qualify if you...
- Significant co-morbidities including left ventricular ejection fraction below 50%
- Creatinine clearance less than 30 ml/min
- Elevated bilirubin above 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis)
- Liver enzymes ALT and AST greater than 5 times the upper limit of normal
- Lung function FEV1 and FVC below 50% predicted or DLCO below 50% once corrected for anemia
- Karnofsky performance score below 70
- Active viral hepatitis or HIV infection
- Cirrhosis
- Pregnancy or breastfeeding
- Inability to provide informed consent
- Previous radiation to more than 20% of bone marrow-containing areas
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
M
Matias Sanchez, MD
CONTACT
M
Marisol Vega, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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