225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome

This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may bl

Trial Details

NCT ID
NCT06287944
Phase
PHASE1
Sponsor
City of Hope Medical Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Actinium Ac 225-DOTA-Daratumumab
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Daratumumab
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
  • ≥ 70 years. Note: Patients ≥ 18 years and \< 70 years with active, relapsed or refractory, or high-risk acute leukemia or MDS as defined below.
  • Karnofsky performance status ≥ 70

For full eligibility, visit ClinicalTrials.gov.

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