RECRUITING

Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients with High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)

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Conditions

Acute Myeloid Leukemia, Relapsed, AdultAcute Myeloid Leukemia RefractoryChronic Myeloid Leukemia - Accelerated PhaseMyelodysplastic SyndromesTotal Marrow IrradiationStem Cell TransplantAllogenic 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

The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.

Official Title

A Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Myeloablative Fludarabine/Busulfan and Post-Transplant Cyclophosphamide (PTCY) for Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients with High-Risk AML, CML, and MDS

Quick Facts

Study Start:2025-03
Study Completion:2032-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06802315

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1. Age 18-65 years.
  2. * 2. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as \<5% bone marrow blasts morphologically:
  3. * AML arising from MDS, a myeloproliferative disorder, or secondary AML
  4. * Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
  5. * 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. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features:
  6. * Poor-risk cytogenetics including 3q abnormalities, 7/7q minus or complex cytogenetics (\>3 abnormalities).
  7. * Current or previous INT-2 or high IPSS score.
  8. * Treatment-related MDS.
  9. * MDS diagnosed before the age of 21 years.
  10. * Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy.
  11. * Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase.
  1. * 1. Presence of significant co-morbidity as shown by:
  2. * 1a. Left ventricular ejection fraction \< 50%
  3. * 2b. Creatinine clearance \<30ml/min.
  4. * 3c. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN.
  5. * 4d. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia.
  6. * 5e. Karnofsky score \<70
  7. * 6f. Active viral hepatitis or HIV infection.
  8. * 7g. Cirrhosis.
  9. * 2. Pregnancy or breast feeding
  10. * 3. Patients unable to sign informed consent.
  11. * 4. Patients previously received radiation to \>20% of bone marrow-containing areas.

Contacts and Locations

Study Contact

Matias Sanchez, MD
CONTACT
(312) 413-4260
matiass@uic.edu
Marisol Vega, MPH
CONTACT
(312) 413-5035
vegam35@uic.edu

Principal Investigator

Matias Sanchez, 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

  • Matias Sanchez, 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 Date2025-03
Study Completion Date2032-03

Study Record Updates

Study Start Date2025-03
Study Completion Date2032-03

Terms related to this study

Keywords Provided by Researchers

  • Total Marrow Irradiation
  • Stem Cell Transplant
  • Allogenic Transplant

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia, Relapsed, Adult
  • Acute Myeloid Leukemia Refractory
  • Chronic Myeloid Leukemia - Accelerated Phase
  • Myelodysplastic Syndromes