Actively Recruiting
Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) Added to Fludarabine/Cyclophosphamide and Post-Transplant Cyclophosphamide Conditioning for Partially HLA Mismatched Allogeneic Transplant in Acute Leukemia and Myelodysplastic Syndrome
Led by University of Illinois at Chicago · Updated on 2026-04-06
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with acute leukemia and myelodysplastic syndrome (MDS) to see if adding a targeted form of radiation called Intensity Modulated Total Marrow Irradiation (IM-TMI) to the usual chemotherapy-based conditioning regimen before haploidentical stem cell transplant can better kill cancer cells in the bone marrow and lower the risk of disease return. This is a phase II clinical trial focusing on a specific transplant preparation approach. Participants will receive a standard conditioning treatment including chemotherapy drugs fludarabine and cyclophosphamide, along with total body irradiation, before receiving a stem cell transplant from a partially matched donor. The IM-TMI radiation is given as a small dose twice daily on days -3 and -2 before transplant, combined with other drugs to prevent graft-versus-host disease after transplant. The full treatment spans several days leading up to and following the transplant. During the study, participants will be closely monitored with assessments of their survival without graft-versus-host disease or relapse at one year as the main outcome. Additional measurements include rates of toxic side effects, success of stem cell engraftment, donor cell presence, overall survival, and disease progression. Follow-up visits and tests will continue for at least one year after the transplant to track these outcomes and ensure safety throughout the process.
CONDITIONS
Brief Title
BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 to 75 years
- Related donor who is at least haploidentical or mismatched unrelated donor
- Diagnosed with relapsed or refractory acute leukemia, poor-risk AML or ALL in first remission, myelodysplastic syndromes with poor-risk features, or mixed lineage/biphenotypic leukemia
- Adequate heart and lung function including left ventricular ejection fraction at least 40%, bilirubin 2.0 mg/dL or less (except Gilbert's or hemolysis), ALT and AST less than 5 times upper limit of normal, and FEV1 and FVC greater than 50% of predicted
You will not qualify if you...
- Significant co-morbidity including left ventricular ejection fraction below 40%
- Bilirubin greater than 2.0 mg/dL (unless Gilbert's syndrome or hemolysis), ALT and AST greater than 5 times upper limit of normal
- Lung function FEV1, FVC, or DLCO less than 50% of predicted
- Karnofsky score below 70
- History of cirrhosis
- Unable to sign informed consent
- Prior 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive a conditioning regimen that includes chemotherapy and radiation to prepare for stem cell transplant.
Daily visits from Day -6 to Day 0
Duration - 1 day
Participants undergo stem cell infusion on Day 0.
1 visit (in-person) on Day 0
Duration - Up to 4 days
Participants receive post-transplant chemotherapy and immunosuppressive medications to prevent complications.
Visits on Days 3 and 4 after transplant
Duration - Up to 1 year
Participants are monitored for safety, graft-versus-host disease, and treatment outcomes for up to 1 year after transplant.
Regular follow-up visits during the first year after transplant
Trial Site Locations
Total: 1 location
1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
R
Rondelli Damiano, MD
M
Marisol Vega, MS
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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