Gilteritinib + Ivosidenib/Enasidenib for Acute Myeloid Leukemia
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Gilteritinib for treating Acute Myeloid Leukemia?
Gilteritinib has been shown to improve survival and response rates in patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations, compared to standard chemotherapy. It is effective as a single-agent treatment and is well-tolerated, making it a valuable option for these patients.12345
Is the combination of Gilteritinib and Ivosidenib/Enasidenib safe for treating acute myeloid leukemia?
Gilteritinib has been shown to be generally safe in humans, with common side effects including anemia (low red blood cell count), febrile neutropenia (fever with low white blood cell count), and thrombocytopenia (low platelet count). Serious but manageable side effects include differentiation syndrome (a potentially life-threatening condition), QT interval prolongation (heart rhythm changes), and pancreatitis (inflammation of the pancreas). Safety data for Ivosidenib and Enasidenib are not provided in the available research.12346
What makes the drug combination of Gilteritinib, Ivosidenib, and Enasidenib unique for treating acute myeloid leukemia?
This drug combination is unique because it targets specific genetic mutations in acute myeloid leukemia, such as FLT3 and IDH mutations, using oral medications that are more convenient and potentially less toxic than traditional chemotherapy. Gilteritinib is a potent FLT3 inhibitor, while Ivosidenib and Enasidenib target IDH1 and IDH2 mutations, respectively, offering a personalized approach to treatment.12346
What is the purpose of this trial?
The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations. The researchers will also look for the highest dose of the combination of gilteritinib with ivosidenib or enasidenib that causes few or mild side effects. When the highest safe dose is found, they will test that dose in new groups of participants.
Research Team
Eytan Stein, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults over 18 with relapsed or refractory Acute Myeloid Leukemia (AML) and specific gene mutations (FLT3/IDH1 or FLT3/IDH2). They must be able to follow the study plan, have adequate organ function, and not be pregnant. Men and women must agree to use birth control. Exclusions include uncontrolled infections, severe leukemia complications, heart issues, absorption problems, certain neurological diseases, and those on other cancer trials.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the combination of gilteritinib with ivosidenib or enasidenib in continuous 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enasidenib
- Gilteritinib
- Ivosidenib
Enasidenib is already approved in United States, European Union for the following indications:
- Relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation
- Acute myeloid leukaemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Astellas Pharma US, Inc.
Industry Sponsor
Naoki Okamura
Astellas Pharma US, Inc.
Chief Executive Officer since 2023
Not available
Tadaaki Taniguchi
Astellas Pharma US, Inc.
Chief Medical Officer since 2023
MD, PhD