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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 23, 2025

Primary Completion Date

March 9, 2028

Study Completion Date

November 29, 2028

Conditions
Acute Myeloid LeukemiaAcute Undifferentiated LeukemiaMixed Phenotype Acute LeukemiaRecurrent Acute Myeloid LeukemiaRecurrent Acute Undifferentiated LeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent Mixed Phenotype Acute LeukemiaRecurrent Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory Acute Undifferentiated LeukemiaRefractory Chronic Myelomonocytic LeukemiaRefractory Mixed Phenotype Acute LeukemiaRefractory Myelodysplastic Syndrome
Interventions
DRUG

Decitabine

Given IV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and/or biopsies

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and/or biopsies

PROCEDURE

Chest Radiography

Undergo chest X-rays

DRUG

Cytarabine

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine

Given IV

PROCEDURE

Hematopoietic Cell Transplantation

Given via infusion

DRUG

Idarubicin

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Pheresis

Undergo apheresis

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Biospecimen Collection

Undergo collection of blood

Trial Locations (1)

98109

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
lead

Fred Hutchinson Cancer Center

OTHER

NCT06928662 - 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 | Biotech Hunter | Biotech Hunter