Actively Recruiting
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
Led by Fred Hutchinson Cancer Center · Updated on 2025-11-06
36
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The FLAG-Ida regimen consists of the following drugs: fludarabine, cytarabine, filgrastim, and idarubicin. These are chemotherapy drugs that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils, a type of white blood cell. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is radiation therapy to the entire body. Giving chemotherapy and TBI before a donor peripheral blood stem cell (PBSC) transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. Giving decitabine in combination with FLAG-Ida and TBI before donor PBSC transplant may work better than FLAG-Ida and TBI alone in treating adult patients with myeloid malignancies at high risk of relapse.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with a Hematopoietic Cell Transplant (HCT) co-morbidity index of 5 or less for patients over 60 years
- Diagnosis of acute myeloid leukemia (AML), acute undifferentiated leukemia, or mixed phenotype acute leukemia that is primary refractory or in untreated or unsuccessfully treated relapse
- Diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) previously treated with hypomethylating agents or chemotherapy, including those progressed to secondary AML
- Prior treatment with hypomethylating agents or chemotherapy allowed, including certain prior FLAG-Ida or CLAG-M regimens
- Use of hydroxyurea or limited cytarabine doses allowed before study treatment
- Karnofsky performance score of 70 or higher and ECOG score of 0 or 1
- Adequate heart function without severe heart failure and left ventricular ejection fraction 45% or higher
- Bilirubin 2.5 times or less the institutional upper limit unless due to certain conditions
- Adequate lung function without oxygen needs and specified diffusion capacity or oxygen levels
- Creatinine clearance over 60 mL/min
- Prior autologous hematopoietic cell transplant allowed if relapse occurred more than 6 months after transplant
- Prior total body irradiation-containing allogeneic transplant up to 3 Gy allowed if more than 6 months after transplant
- Availability of a suitable human leukocyte antigen (HLA)-matched sibling, unrelated, mismatched unrelated, or haploidentical donor
- Ability to understand and sign informed consent
- Donor requirements based on HLA matching and screening criteria including age and weight for haploidentical donors
You will not qualify if you...
- Active central nervous system disease
- Serious illness expected to limit survival to less than 1 year
- Active uncontrolled systemic fungal, bacterial, viral, or other infections, except fever likely due to myeloid malignancy
- Known allergy or contraindication to any study medication
- Pregnancy or breastfeeding
- Concurrent treatment with other approved or investigational anti-leukemia agents
- For haploidentical donors, presence of anti-donor-specific antibodies above defined levels without successful desensitization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
N
Naveed Ali, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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