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

NCT04187105 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 2019-1149
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Leukemia; MDS

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival

  To evaluate the number of patients with acute leukemia or MDS who are GVHD-free, relapse free (GRFS) after 1 year of undergoing undergoing a treatment regimen of haploidentical stem cell transplant with conditioning and total marrow irradiation.

  1 year

Secondary Outcomes (9)

• The number of patients with greater than or equal to grade 4 non-hematologic toxicities

  1 year post-stem cell transplant

• Engraftment rates

  30 days post-stem cell transplant

• Rates of incidence of full donor chimerism

  30 days post-stem cell transplant

• The rate of overall survival (OS)

  1 year post-stem cell transplant

• The rate of event free-survival (EFS)

  1 year post-stem cell transplant

Study Arms (1)

Conditioning regimen with half-matched (haploidentical) stem cell transplant

OTHER

Radiation: Conditioning regimen with half-matched (haploidentical) stem cell transplant; Drug: Conditioning regimen with half-matched (haploidentical) stem cell transplant; Device: Conditioning regimen with half-matched (haploidentical) stem cell transplant; Other: Conditioning regimen with half-matched (haploidentical) stem cell transplant

Interventions

Conditioning regimen with half-matched (haploidentical) stem cell transplant RADIATION

Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2

Also known as: Total Marrow Irradiation

Conditioning regimen with half-matched (haploidentical) stem cell transplant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18-75 years
• 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.
• 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:

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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Interventions

Transplantation Conditioning; Stem Cell Transplantation; fludarabine; Cyclophosphamide; Whole-Body Irradiation; Mesna; Tacrolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Cell Transplantation; Cell- and Tissue-Based Therapy; Transplantation; Surgical Procedures, Operative; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Radiotherapy; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Macrolides; Lactones; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Rondelli Damiano, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rondelli Damiano, MD

CONTACT

312-996-6179; drond@uic.edu

Marisol Vega, MS

CONTACT

312-335-5035; vegam35@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single group assignment to Arm 1

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: December 5, 2019
• Study Start: January 27, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)