Actively Recruiting
CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
Led by Fred Hutchinson Cancer Center · Updated on 2026-03-05
120
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies the best dose of total body irradiation when given with cladribine, cytarabine, filgrastim, and mitoxantrone (CLAG-M) or idarubicin, fludarabine, cytarabine and filgrastim (FLAG-Ida) chemotherapy reduced-intensity conditioning regimen before stem cell transplant in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Giving chemotherapy and total body irradiation before a donor peripheral blood stem cell 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 and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells called graft versus host disease. Giving cyclophosphamide, cyclosporine, and mycophenolate mofetil after the transplant may stop this from happening.
CONDITIONS
Official Title
CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) of 5 or less for patients over 60 years
- Diagnosis of acute myeloid leukemia (AML) that is primary refractory or in untreated/unsuccessfully treated relapse, including minimal residual disease positive patients
- Diagnosis of relapsed or refractory acute leukemia of ambiguous lineage
- Previously treated myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) with disease progression or relapse after hypomethylating agent treatment
- Use of hydroxyurea before study treatment is allowed
- Karnofsky score 70 or higher; ECOG performance status 0-1
- Adequate cardiac function with left ventricular ejection fraction 45% or higher
- Bilirubin less than or equal to 2.5 times institutional upper limit unless due to disease infiltration or other specific causes
- Adequate lung function without oxygen requirement and DLCO corrected 70% or higher, or 60-69% with pO2 70 mmHg or higher
- Serum creatinine less than or equal to 1.5 mg/dL
- Prior autologous hematopoietic cell transplant allowed if relapse occurred more than 3 months but less than or equal to 6 months after transplant
- Prior TBI-containing allogeneic transplant up to 3 Gy allowed if more than 6 months after transplant
- A suitable HLA-matched or near-matched donor available and ready for stem cell donation
- Agreement to use contraception from consent signing until at least 12 months post-transplant
- Ability to understand and sign informed consent
- Donor must meet specified HLA matching and eligibility criteria
You will not qualify if you...
- Patients 18 years or older treated at Seattle Children's Hospital
- Active central nervous system disease
- Illness likely to limit survival to less than 1 year
- Active systemic infections not controlled or stable, except fever likely due to myeloid malignancy
- Known allergy or contraindication to any study drug
- Pregnancy or breastfeeding
- Concurrent treatment with other approved or investigational anti-leukemia agents
- Presence of anti-donor specific antibodies above threshold not resolved by desensitization treatment for haploidentical donor recipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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