Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse

This phase I/II trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called h

Trial Details

NCT ID
NCT06928662
Phase
PHASE1 / PHASE2
Sponsor
Fred Hutchinson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Decitabine
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Chest Radiography
  • Cytarabine
  • Echocardiography Test
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Age ≥ 18 years with an HCT-co-morbidity index (CI) ≤ 5 for patients over 60 years.
  • AML (2022 World Health Organization \[WHO\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy…
  • MDS and CMML: Subjects with previously treated MDS and CMML, defined as prior treatment with at least one hypomethylating agent (hypomethylating ag…
  • Patients may have previously received hypomethylating agents or chemotherapy with a mitoxantrone, idarubicin- or cladribine/fludarabine-based regim…

For full eligibility, visit ClinicalTrials.gov.

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