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

Recruiting now · Phase 2

Conditions studied: Acute Leukemia, MDS

In brief

This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).

Key facts

Study ID

NCT04187105

Run by

University of Illinois at Chicago

People needed

27

Starts

2020-01-27

Expected to finish

2026-12-01

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age 18-75 years
• Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.
• 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.
• Eligible diagnoses are listed below. Patient must have one of the following:
• Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia).
• Poor-risk AML in first remission:
• 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
• 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
• 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
• Mixed lineage and biphenotypic leukemia

You may not qualify if…

• Presence of significant co morbidity as shown 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 or DLCO <50% of predicted once corrected for anemia
• d. Karnofsky score <70
• e. History of cirrhosis
• Patients unable to sign informed consent
• Patient who have previously received radiation to >20% of bone marrow containing areas (assessed by radiation oncology physician)

Where it is running

• University of Illinois Cancer Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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