Actively Recruiting
Pilot Study of FLAG-Ida Followed Immediately by Reduced-Intensity Allogeneic HCT for Adults Age 60 and Older With Newly Diagnosed Adverse-Risk AML or Other High-Grade Myeloid Neoplasm
Led by Fred Hutchinson Cancer Center · Updated on 2026-01-30
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new treatment approach for adults aged 60 and older with newly diagnosed adverse-risk acute myeloid leukemia (AML) or other high-grade myeloid cancers. This phase II trial evaluates the safety, side effects, and effectiveness of a combination chemotherapy regimen called FLAG-Ida, followed immediately by reduced-intensity total body irradiation (TBI) and donor hematopoietic cell transplant (HCT). Despite advances in treatment, outcomes for older adults with these aggressive blood cancers remain poor, and this study aims to improve results by reducing complications related to low blood cell counts. Participants receive granulocyte colony-stimulating factor (G-CSF) injections daily for several days, along with intravenous doses of fludarabine, high-dose cytarabine, and idarubicin over several consecutive days. Following chemotherapy, patients undergo total body irradiation over one or two days at a lower intensity. After radiation, they receive an allogeneic hematopoietic cell transplant using donor peripheral blood stem cells. Treatment continues as long as the disease does not progress and side effects remain manageable. Additional procedures include heart function tests (MUGA or echocardiography), bone marrow biopsies or aspirations, and blood sample collections throughout the study. Participants are monitored closely during and after treatment with follow-up visits scheduled at days 28, 56, and 80, then at 3 months, 6 months, and yearly up to 2 years. Researchers assess outcomes such as the proportion of patients starting treatment within 42 days of consent, time to transplant, adverse events, blood cell recovery, graft versus host disease, remission rates, measurable residual disease, relapse-free survival, and overall survival. Safety and tolerability are key aspects, with detailed evaluations of blood counts, organ function, and transplant success throughout the study period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older, or under 60 if unsuitable for myeloablative conditioning as assessed by a physician
- Ability and willingness to provide informed consent or have a legally authorized representative do so
- Newly diagnosed, untreated high-risk myeloid or mixed myeloid/lymphoid neoplasm, including adverse-risk AML, acute leukemia of ambiguous lineage, high-risk myelodysplastic neoplasm, or high-risk chronic myelomonocytic leukemia
- Prior low-intensity treatment for MDS or CMML allowed, but no prior hypomethylating agents
- Disease not requiring immediate anti-cancer therapy; supportive cytoreduction allowed
- Interest in pursuing allogeneic hematopoietic cell transplant
- Availability of a caregiver
- Karnofsky score of 70 or higher; ECOG performance status of 0-2
- Bilirubin less than or equal to 2.5 times institutional upper limit unless due to specific causes
- Serum creatinine less than or equal to 1.5 mg/dL
- Prior autologous HCT allowed if more than 6 months before planned transplant
- Use of two effective contraceptive methods for participants of childbearing potential
- HIV patients with undetectable viral load on effective therapy
- Controlled hepatitis B or cured hepatitis C infection
- Prior or concurrent malignancies allowed if not interfering with study
- Availability of an HLA-matched or haploidentical donor meeting specific criteria
You will not qualify if you...
- Active central nervous system disease
- Severe heart conditions or significant cardiac history preventing transplant
- Significant pulmonary disease or symptoms preventing transplant
- Treatment with other anti-leukemia agents at treatment start
- Concomitant illnesses expected to limit survival to less than 1 year
- Active uncontrolled infections other than fever due to malignancy
- Known allergies or contraindications to study drugs including post-transplant cyclophosphamide
- Pregnancy or breastfeeding
- Psychiatric or social conditions limiting study compliance
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. During screening, participants undergo multigated acquisition scan (MUGA) or echocardiography (ECHO) as clinically indicated.
1 screening and enrollment visit
Duration - Approximately 10 to 12 days
Participants receive combination chemotherapy with granulocyte colony-stimulating factor (SC) daily on days -9 to -4 or -7 to -4, fludarabine (IV), cytarabine (IV), and idarubicin (IV) on specified days. Participants then undergo total-body irradiation (TBI) on days -1 and 0 or twice daily on day -1 or 0 followed immediately by allogeneic hematopoietic cell transplant (HCT) with peripheral blood stem cells.
Daily visits during chemotherapy and radiation as clinically indicated; transplant occurs on day 0 or 1 after TBI
Duration - Up to 2 years
After treatment completion, participants are followed up with blood sample collections and bone marrow biopsies or aspirations as needed. Follow-up visits occur to monitor recovery and assess long-term outcomes.
Visits at days 28, 56, 80; months 3 and 6; and years 1 and 2
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
F
Filippo Milano, MD, PhD
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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