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BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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 (Haploidentical) Allogeneic Transplantation in Patients With Acute Leukemia and Myelodysplastic Syndrome (MDS)

NCT04187105•University of Illinois at Chicago

View on ClinicalTrials.gov

Summary

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).

Detailed Description

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient age 18-75 years
•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)
+17 more criteria

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)

Locations (1)

University of Illinois Cancer Center

Chicago, Illinois, United States

Key Dates

Start Date

January 27, 2020

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

Acute LeukemiaMDS

Interventions