RECRUITING

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

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Conditions

Acute LeukemiaMDSStem Cell TransplantHalf-matched (haploidentical) stem cell transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2020-01-27
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04187105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient age 18-75 years
  2. 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. 3. Eligible diagnoses are listed below. Patient must have one of the following:
  4. 1. Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia).
  5. 2. Poor-risk AML in first remission:
  6. * AML arising from MDS or a myeloproliferative disorder, or secondary AML
  7. * Poor risk molecular features including but not limited to presence of FLT3 internal tandem duplication mutation.
  8. * 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
  9. 3. Poor risk ALL in first remission:
  10. * 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)
  11. * Philadelphia-like ALL
  12. * Presentation WBC \>30 × 109 for B-ALL or \>100 109 for T-ALL
  13. * Age\>35
  14. * Poor MRD clearance, defined as levels \>1 × 10-3 after induction and levels \>5 × 10-4 after early consolidation by flow cytometry
  15. 4. Myelodysplastic syndromes (MDS) with at least one of the following poor-risk features:
  16. * i. Poor-risk cytogenetics (including but not limited to 7/7q minus or complex cytogenetics)
  17. * ii. IPSS score of INT-2 or greater
  18. * iii. Treatment-related or Secondary MDS
  19. * iv. MDS diagnosed before age 21 years
  20. * v. Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy
  21. * vi. Life-threatening cytopenias, including those generally requiring greater than weekly transfusions
  22. * vii. Poor risk molecular features including but not limited to the presence of BCOR, ASXL1, p53 or RUNX1 mutations
  23. 5. Mixed lineage and biphenotypic leukemia
  24. 4. Adequate end-organ function as measured by:
  25. * a. Left ventricular ejection fraction ≥ 40%
  26. * b. Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \< 5 x ULN
  27. * c. FEV1 and FVC \> 50% of predicted
  1. 1. Presence of significant co morbidity as shown by:
  2. * a. Left ventricular ejection fraction \< 40%
  3. * b. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN
  4. * c. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia
  5. * d. Karnofsky score \<70
  6. * e. History of cirrhosis
  7. 2. Patients unable to sign informed consent
  8. 3. Patient who have previously received radiation to \>20% of bone marrow containing areas (assessed by radiation oncology physician)

Contacts and Locations

Study Contact

Rondelli Damiano, MD
CONTACT
312-996-6179
drond@uic.edu
Marisol Vega, MS
CONTACT
312-335-5035
vegam35@uic.edu

Principal Investigator

Rondelli Damiano, MD
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago

Study Locations (Sites)

University of Illinois Cancer Center
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-27
Study Completion Date2026-12

Study Record Updates

Study Start Date2020-01-27
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Stem Cell Transplant
  • Half-matched (haploidentical) stem cell transplant

Additional Relevant MeSH Terms

  • Acute Leukemia
  • MDS