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IM-TMI for Acute Leukemia and MDS

This study is testing a new way to deliver radiation called Intensity Modulated Total Marrow Irradiation (IM-TMI) before a stem cell transplant. The goal is to see if adding IM-TMI to the standard conditioning regimen (fludarabine, cyclophosphamide, and total body irradiation) can kill more cancer cells and reduce the chance of your acute leukemia or myelodysplastic syndromes (MDS) returning. You may be able to join if you are between 18 and 75 years old and have a suitable related donor. The main thing researchers will look at is how many people are free from both graft-versus-host disease (GVHD) and relapse one year after the transplant. The current recruitment status is unclear.

Study design
This is a single-arm Phase II study, meaning all 27 participants will receive the same treatment. It is not specified if the study is open-label or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at one year, so participants will be followed for at least one year after the stem cell infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04187105

BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)

Recruiting
PHASE2Ages 18–75InterventionalTreatment
University of Illinois at Chicago
~27 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Conditioning regimen with half-matched (haploidentical) stem cell transplant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival
Measured over 1 year

Conditions

Acute Leukemia
MDS

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Acute LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeASXL1 GeneBCOR GeneReceptor-Type Tyrosine-Protein Kinase FLT3RUNX1 GeneTP53 Gene

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Rondelli Damiano, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Rondelli Damiano, MD
[email protected]
312-996-6179
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4/8 if using HLA-A,-B,-DRB1,-Cw, or 5/10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype.
Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4/8 or 5/10 mismatches. 3. Eligible diagnoses are listed below. Patient must have one of the following:
AML arising from MDS or a myeloproliferative disorder, or secondary AML
Poor risk molecular features including but not limited to presence of FLT3 internal tandem duplication mutation.
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 3. Poor risk ALL in first remission:
Poor risk cytogenetics: Philadelphia Chromosome, t(4;11), KMT2A translocation, t(8;14), complex karyotype (⩾ 5 chromosomal abnormalities) and low hypodiploidy (30-39 chromosomes)/near triploidy (60-78 chromosomes)
Philadelphia-like ALL
Presentation WBC \>30 × 109 for B-ALL or \>100 109 for T-ALL
Age\>35
Poor MRD clearance, defined as levels \>1 × 10-3 after induction and levels \>5 × 10-4 after early consolidation by flow cytometry 4. Myelodysplastic syndromes (MDS) with at least one of the following poor-risk features:
i. Poor-risk cytogenetics (including but not limited to 7/7q minus or complex cytogenetics)
ii. IPSS score of INT-2 or greater
iii. Treatment-related or Secondary MDS
iv. MDS diagnosed before age 21 years
v. Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy
vi. Life-threatening cytopenias, including those generally requiring greater than weekly transfusions
vii. Poor risk molecular features including but not limited to the presence of BCOR, ASXL1, p53 or RUNX1 mutations 5. Mixed lineage and biphenotypic leukemia 4. Adequate end-organ function as measured by:
a. Left ventricular ejection fraction ≥ 40%
b. Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \< 5 x ULN
c. FEV1 and FVC \> 50% of predicted

Exclusion

a. Left ventricular ejection fraction \< 40%
b. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN
c. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia
d. Karnofsky score \<70
e. History of cirrhosis 2. Patients unable to sign informed consent 3. Patient who have previously received radiation to \>20% of bone marrow containing areas (assessed by radiation oncology physician)

What this trial measures

  • Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival1 year

    To evaluate the number of patients with acute leukemia or MDS who are GVHD-free, relapse free (GRFS) after 1 year of undergoing undergoing a treatment regimen of haploidentical stem cell transplant with conditioning and total marrow irradiation.