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

NCT04187105 · University of Illinois at Chicago
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Official title
BMT-06: Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Cyclophosphamide and Post-Transplant Cyclophosphamide Conditioning for Partially HLA Mismatched Allogeneic Transplantation in Patients With Acute Leukemia and Myelodysplastic Syndrome (MDS)
About this study
This is a single arm phase II clinical trial. The usual conditioning regimen for haploidentical transplant is the use of chemotherapy (fludarabine/cyclophosphamide) before the transplant and further chemotherapy with cyclophosphamide after the transplant. In addition, a small dose of radiation is also given. Patients will receive a standard conditioning regimen with fludarabine, cyclophosphamide and total body irradiation (Flu/Cy/TBI) prior to haploidentical hematopoietic stem cell transplant (HSCT). Graft-versus-host disease prophylaxis will include cyclophosphamide 50 mg/kg on Day +3 and 4 along with tacrolimus and mycophenolate mofetil.
Eligibility criteria
Inclusion Criteria: 1. Patient age 18-75 years 2. 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. 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 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 Criteria: 1. 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 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)
Study design
Enrollment target: 27 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-01-27
Estimated completion: 2026-12
Last updated: 2026-04-06
Interventions
Radiation: Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug: Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug: Conditioning regimen with half-matched (haploidentical) stem cell transplantDevice: Conditioning regimen with half-matched (haploidentical) stem cell transplantOther: Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug: Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug: Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug: Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug: Conditioning regimen with half-matched (haploidentical) stem cell transplantDrug: Conditioning regimen with half-matched (haploidentical) stem cell transplant
Primary outcomes
  • Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival (1 year)
Sponsor
University of Illinois at Chicago · other
Contacts & investigators
ContactRondelli Damiano, MD · contact · drond@uic.edu · 312-996-6179
ContactMarisol Vega, MS · contact · vegam35@uic.edu · 312-335-5035
InvestigatorRondelli Damiano, MD · principal_investigator, University of Illinois at Chicago
All locations (1)
University of Illinois Cancer CenterRecruiting
Chicago, Illinois, United States