Combination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hematopoietic Cell Transplant for the Treatment of Adults Age 60 and Older With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia or Other High-Grade Myeloid Cancer

Description

OUTLINE:

Patients receive granulocyte colony-stimulating factor subcutaneously (SC) once daily (QD) on days -9 to -4 or days -7 to -4 as clinically indicated, fludarabine intravenously (IV) over 30 minutes QD on days -8 to -4, cytarabine IV over 2 hours QD on days -8 to -4, and idarubicin IV over 60 minutes QD on days -8 to -6. Patients undergo TBI QD on days -1 and 0 or twice daily (BID) on day 0. Patients then undergo allogeneic HCT with unmodified peripheral blood stem cells IV on day 0 or 1 day after TBI as clinically indicated. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo multigated acquisition scan (MUGA) or echocardiography (ECHO) during screening and as clinically indicated, undergo bone marrow biopsy and/or aspiration throughout the study and blood sample collection during follow up.

After completion of study treatment, patients are followed up at days 28, 56 and 80, at months 3 and 6 and at years 1 and 2.