Olaparib for Acute Myeloid Leukemia with IDH Mutation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies how well olaparib works in patients with AML or MDS that has come back or does not respond to treatment, and who have an IDH mutation. Olaparib is a pill that may help stop cancer cells from growing by blocking certain enzymes they need. The study aims to see if olaparib is better than other treatments. Olaparib has shown benefits in various cancers, including breast and ovarian cancers.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) for strong or moderate CYP3A inducers and inhibitors before starting olaparib. If you are taking these types of medications, you may need to stop them for a few weeks before joining the trial. It's best to discuss your specific medications with the trial team.
Is Olaparib generally safe for humans?
Olaparib (also known as Lynparza) has been used in treating various cancers like ovarian, breast, pancreatic, and prostate cancer, and is generally considered safe. However, there are some concerns about rare side effects, such as myelodysplastic syndrome (a blood disorder) and acute myeloid leukemia, which have been reported in some cases.12345
How does the drug Olaparib differ from other treatments for acute myeloid leukemia with IDH mutation?
Olaparib is unique because it is a PARP inhibitor that targets cancer cells with IDH mutations, which have a specific defect in DNA repair, making them more sensitive to this drug. Unlike standard chemotherapy, Olaparib is taken orally and specifically kills leukemic cells while sparing normal cells, offering a potential treatment for patients who do not respond to or relapse after other targeted therapies.678910
What data supports the effectiveness of the drug Olaparib for treating acute myeloid leukemia with IDH mutation?
Research shows that Olaparib can kill leukemia cells in most acute myeloid leukemia (AML) samples while sparing healthy cells, suggesting it might be effective for AML patients. Additionally, Olaparib is already used successfully in treating certain types of ovarian and breast cancers, indicating its potential in other cancer treatments.1461112
Who Is on the Research Team?
Rory M. Shallis
Principal Investigator
Yale University Cancer Center LAO
Are You a Good Fit for This Trial?
Adults diagnosed with relapsed or refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with an IDH mutation, who have tried first-line therapy without success. Participants must be in stable health otherwise, not pregnant, and willing to use contraception. Those with uncontrolled infections, other active cancers needing treatment, or known hypersensitivity to olaparib are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olaparib orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 90 days and then every 3 months until death.
What Are the Treatments Tested in This Trial?
Interventions
- Olaparib
Olaparib is already approved in European Union, United States for the following indications:
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor