Decitabine + FLAG-Ida for Myeloid Malignancies
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on any other approved or investigational anti-leukemia treatments while participating in this trial.
What data supports the effectiveness of the Decitabine + FLAG-Ida treatment for myeloid malignancies?
Research shows that the combination of Decitabine with FLAG-Ida has been effective in treating acute myeloid leukemia (AML), with studies reporting complete remission rates of over 50% in patients with relapsed or refractory AML. This suggests that the treatment can be effective in managing difficult cases of AML.12345
Is the Decitabine + FLAG-Ida treatment generally safe for humans?
The Decitabine + FLAG-Ida treatment, which includes drugs like cytarabine, idarubicin, and filgrastim, has been studied for safety in people with myeloid malignancies. Common side effects include infections, especially in the lungs, and conditions like mucositis (painful inflammation and ulceration of the mucous membranes) and pulmonary toxicity (lung damage). While some patients experienced severe side effects, the overall safety profile is considered acceptable for high-risk patients.25678
How is the drug Decitabine + FLAG-Ida unique for treating myeloid malignancies?
The combination of Decitabine with FLAG-Ida is unique because it uses Decitabine as an 'epigenetic priming' agent, which means it helps make cancer cells more sensitive to chemotherapy by altering gene expression. This approach is particularly useful for patients with acute myeloid leukemia (AML) who have not responded to other treatments, offering a new option for those with difficult-to-treat cases.3491011
What is the purpose of this trial?
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.
Research Team
Naveed Ali, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
Adults with high-risk myeloid malignancies, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML) who are candidates for a stem cell transplant. Participants should not have other health conditions that could interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy and Radiation
Participants receive decitabine, FLAG-Ida regimen, and total body irradiation before donor stem cell transplantation
Transplantation
Participants undergo hematopoietic cell transplantation (HCT) with donor peripheral blood stem cells
Follow-up
Participants are monitored for safety, effectiveness, and disease response after treatment
Treatment Details
Interventions
- Cytarabine
- Decitabine
- Filgrastim
- Idarubicin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor