Ipilimumab + Decitabine for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of ipilimumab when given together with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as decitabine, 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. Giving ipilimumab and decitabine may work better in treating patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.
Will I have to stop taking my current medications?
The trial requires that you stop taking systemic immunosuppressive medications more than 2 weeks before starting treatment. If you are on systemic corticosteroids, you must reduce the dose to 5 mg/day or less of prednisone (or equivalent) for more than 1 week before starting treatment. Topical steroids are allowed.
What data supports the effectiveness of the drug combination of Ipilimumab and Decitabine for Acute Myeloid Leukemia?
Research shows that Decitabine, when combined with other drugs, has been studied for its effectiveness in treating acute myeloid leukemia (AML), particularly in older patients or those with relapsed or refractory AML. However, there is no direct evidence from the provided studies about the specific combination of Ipilimumab and Decitabine for AML.12345
Is the combination of Ipilimumab and Decitabine safe for humans?
Ipilimumab, used for treating melanoma, can cause immune-related side effects like skin rashes, diarrhea, and inflammation of the colon. Most side effects are mild to moderate, but some can be severe. Decitabine, often used for blood cancers, has its own side effects, but specific safety data for the combination with Ipilimumab is not available.678910
What makes the drug combination of Ipilimumab and Decitabine unique for treating acute myeloid leukemia?
The combination of Ipilimumab and Decitabine for acute myeloid leukemia is unique because it pairs an immune checkpoint inhibitor (Ipilimumab) with a DNA methylation inhibitor (Decitabine), potentially enhancing the immune system's ability to fight cancer cells while also altering the cancer cell's DNA to make them more susceptible to treatment. This approach is different from standard chemotherapy, which primarily targets rapidly dividing cells.23111213
Research Team
Jacqueline S Garcia
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Eligibility Criteria
This trial is for adults with relapsed or refractory myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Eligible participants may have had certain treatments like chemotherapy, stem cell transplant, and must be in a stable condition. They should not have severe autoimmune diseases, active infections that aren't controlled, other cancers within the last 2 years, or known brain involvement by leukemia.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Priming
Patients receive decitabine intravenously over 60 minutes on days 1-5 out of 28 days
Induction
Patients receive decitabine and ipilimumab intravenously, treatment repeats every 28 days for up to 4 cycles
Maintenance
Patients receive decitabine and ipilimumab intravenously, treatment repeats every 4 or 8 weeks for up to 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Decitabine
- Ipilimumab
Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor