Actively Recruiting
CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study
Led by Fred Hutchinson Cancer Center · Updated on 2026-03-05
120
Participants Needed
1
Research Sites
2 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
Researchers are evaluating the best dose of total body irradiation combined with two chemotherapy regimens, CLAG-M or FLAG-Ida, as part of a reduced-intensity conditioning before donor stem cell transplant in adults with relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia. This phase I trial aims to find the optimal treatment combination to prepare the body for stem cell transplant, which may help replace unhealthy bone marrow and fight remaining cancer cells. The study also monitors prevention of graft versus host disease using specific medications after transplant. The study has two treatment arms. In Arm I, patients receive filgrastim, cladribine, cytarabine, and mitoxantrone chemotherapy over several days before undergoing total body irradiation and hematopoietic cell transplantation. In Arm II, patients receive filgrastim, fludarabine, cytarabine, and idarubicin chemotherapy with similar timing, followed by irradiation and transplant. Both arms include graft versus host disease prevention with cyclophosphamide, cyclosporine, and mycophenolate mofetil given on scheduled days after transplant. Patients receiving unrelated cord blood transplants follow a specific medication schedule. Participants undergo heart scans (MUGA or echocardiography), x-rays, bone marrow biopsies, and blood sample collections during screening and at multiple points up to one year post-transplant. After completing treatment, follow-up visits occur at 100 days, then 6, 12, and 24 months to monitor transplant success, disease progression, and any complications. Researchers measure rates of transplant failure, disease progression, graft versus host disease, adverse events, and remission duration throughout the study.
CONDITIONS
Brief 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) per 2016 WHO criteria that is primary refractory or in untreated or unsuccessfully treated relapse
- Patients with minimal residual disease in morphological remission are eligible
- Relapsed or refractory acute leukemia of ambiguous lineage is eligible
- Previously treated myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) patients with progression or refractory disease after hypomethylating agents
- Karnofsky score of 70 or higher; ECOG performance status 0-1
- Adequate cardiac function (no decompensated heart failure or uncontrolled arrhythmia) and left ventricular ejection fraction of 45% or higher
- Bilirubin 2.5 times or less than institutional upper limit unless due to specific conditions
- Adequate pulmonary function with no oxygen requirement and DLCO corrected at least 70% or 60-69% with pO2 of 70 mmHg or higher
- Serum creatinine 1.5 mg/dL or less
- Prior autologous hematopoietic cell transplant permitted if relapse occurred more than 3 months but 6 months or less after transplant
- Prior low-dose total body irradiation allogeneic transplant permitted if more than 6 months prior
- An HLA-matched or near-matched related, unrelated, or haploidentical donor must be identified and available
- Women of childbearing potential and men must agree to use contraception until 12 months post-transplant
- Ability to understand and sign informed consent
- Donors must meet specific HLA matching and health 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 one year
- Active systemic fungal, bacterial, viral, or other infection unless controlled or stable
- Known allergy or contraindication to any study drug used
- Pregnancy or breastfeeding
- Concurrent treatment with any other approved or investigational anti-leukemia agent
- Patients with anti-donor-specific antibodies above threshold unless successfully desensitized
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 2 months
Participants receive chemotherapy with either CLAG-M or FLAG-Ida regimen followed immediately by total-body irradiation and allogeneic hematopoietic cell transplantation. They also receive graft-versus-host disease prophylaxis with medications after transplantation.
Daily visits for chemotherapy and radiation during the first 9 days, then frequent visits during transplantation and GVHD prophylaxis through day 60
Duration - Up to 24 months post-transplant
Participants are followed up to monitor recovery, disease status, and any adverse events after transplantation and treatment completion.
Visits at 100 days, 6 months, 12 months, and 24 months post-transplant
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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