NCT07046078View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 26, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2029

Conditions
Acute Leukemia of Ambiguous LineageAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic Syndrome
Interventions
PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HCT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and/or aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and/or aspiration

DRUG

Cytarabine

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fludarabine

Given IV

DRUG

Idarubicin

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

BIOLOGICAL

Peripheral Blood Stem Cell

Given IV

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Recombinant Granulocyte Colony-Stimulating Factor

Given SC

RADIATION

Total-Body Irradiation

Undergo TBI

Trial Locations (1)

98109

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
lead

Fred Hutchinson Cancer Center

OTHER

NCT07046078 - 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 | Biotech Hunter | Biotech Hunter