BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)
NCT ID: NCT04187105
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
27 participants
INTERVENTIONAL
2020-01-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Arm1
Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2
Arm1
All patients will receive the following standard conditioning regimen:
Fludarabine 30 mg/m2 IVPB daily from Day -6 (6 days before stem cell infusion) through Day -2
Arm1
IV cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5.
Arm 1
Total body irradiation 2Gy on day -1.
Arm1
Stem cell infusion on day 0.
Arm1
Tacrolimus IV initially in doses of 0.15 mg/kg/day for 3 days, followed by conversion to oral therapy (0.15 mg/kg twice daily)
Arm1
Cyclophosphamide on days 3 and 4 after transplant at a dose of 50mg/kg per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical. The donor and recipient must be identical 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 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype. In addition, unrelated donors who are mismatched at least one of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-or DRB1.
3. Eligible diagnoses are listed below. Patient must have one of the following:
1. Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia).
2. 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
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 e. Mixed lineage and biphenotypic leukemia
4. Adequate end-organ function as measured by:
1. Left ventricular ejection fraction ≥ 40%
2. Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \< 5 x ULN
3. FEV1 and FVC \> 50% of predicted
Exclusion Criteria
1. Left ventricular ejection fraction \< 40%
2. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN
3. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia
4. Karnofsky score \<70
5. 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)
18 Years
75 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Damiano Rondelli, MD
Principal Investigator
Principal Investigators
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Rondelli Damiano, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Illinois Cancer Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Rondelli Damiano, MD
Role: primary
Marisol Vega, MS
Role: backup
Other Identifiers
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2019-1149
Identifier Type: -
Identifier Source: org_study_id