Actively Recruiting
Sequential Decitabine with FLAG-Ida and Reduced-Intensity Conditioning Allogeneic Stem Cell Transplant for Adults with Myeloid Malignancies at High Risk of Relapse
Led by Fred Hutchinson Cancer Center · Updated on 2026-05-15
36
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and optimal dose of decitabine combined with a chemotherapy regimen called FLAG-Ida and total body irradiation (TBI), followed by a donor stem cell transplant in adults with certain blood cancers. These cancers include acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML) that have a high risk of returning after treatment. Decitabine is a medication that helps the bone marrow produce normal blood cells and targets abnormal cells. The study aims to see if adding decitabine improves treatment compared to FLAG-Ida and TBI alone. Participants receive decitabine intravenously daily over one hour for varying days before transplant, along with filgrastim injections, idarubicin, fludarabine, and cytarabine infusions, followed by total body irradiation given either twice daily or once daily just before receiving donor peripheral blood stem cells (PBSCs) via infusion on day 0. Donors undergo apheresis to collect PBSCs. The treatment involves a phase I dose-escalation followed by a phase II study. During the study, patients undergo heart scans (MUGA or echocardiography), chest X-rays, bone marrow biopsies, and blood sample collections. Follow-up visits occur at 6 months, 1 year, and 2 years after treatment to monitor outcomes such as survival without disease return and transplant-related complications. The study measures include disease-free survival at 1 year and non-relapse mortality at day 100.
CONDITIONS
Brief 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; patients over 60 must have a Hematopoietic Cell Transplant co-morbidity index of 5 or less
- Diagnosis of AML, acute undifferentiated leukemia, mixed phenotype acute leukemia, MDS, or CMML as defined by specific treatment history and relapse status
- Patients with AML in morphologic remission but with evidence of minimal residual disease
- Prior treatments allowed include hypomethylating agents or certain chemotherapy regimens under specified conditions
- Karnofsky score of 70 or higher; ECOG performance status 0 or 1
- Adequate heart function with left ventricular ejection fraction of 45% or higher
- Bilirubin less than or equal to 2.5 times the upper limit of normal unless due to certain conditions
- Adequate lung function without oxygen requirement and specific diffusion capacity and oxygen levels
- Creatinine clearance greater than 60 mL/min
- Prior autologous HCT allowed if relapse occurred more than 6 months after
- Certain prior transplant conditions permitted with timing restrictions
- A matched or haploidentical donor must be identified and available
- Ability to understand and sign informed consent
- Donor-specific criteria based on HLA matching and other immunological factors
- Donor age 18 years or older and weight 40 kg or more for haploidentical donors
- Donors screened per established guidelines
You will not qualify if you...
- Active central nervous system disease
- Illness likely to result in survival less than 1 year
- Active uncontrolled infections, except fever related to myeloid malignancy
- Known allergy or contraindication to any study drugs
- Pregnancy or breastfeeding
- Concurrent treatment with other approved or investigational anti-leukemia agents
- For haploidentical donors, presence of anti-donor-specific antibodies above a certain threshold after desensitization treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive chemotherapy including decitabine intravenously daily over several days, filgrastim subcutaneously, idarubicin, fludarabine, and cytarabine intravenously, followed by total-body irradiation and hematopoietic cell transplant via infusion.
Daily visits for up to 3 weeks
Duration - Up to 2 years
Participants are followed up after completion of treatment to monitor health status and disease progression.
Visits at 6 months, 1 year, and 2 years
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here