Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome

This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects relate

Trial Details

NCT ID
NCT07582172
Phase
PHASE2
Sponsor
City of Hope Medical Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Biospecimen Collection
  • Bone Marrow Biopsy
  • Computed Tomography
  • Echocardiography Test
  • Fludarabine Phosphate
  • Melphalan
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729

Key Eligibility Criteria

  • Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval

For full eligibility, visit ClinicalTrials.gov.

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