If you are a patient diagnosed with clonal cytopenia of undetermined significance (CCUS), you may be eligible to participate in the Preventing IDH Mutant Myeloid Neoplasms (PIMMs) trial.
Eligibility
Patients must
- Have had unexplained low blood cell counts for at least six months
- Carry a specific mutation in the gene IDH1 (R132) in their blood
In addition, the following screening exams, tests, or procedures will be needed to determine if you can participate in the study:
- Physical exam/medical history
- Blood tests to confirm presence of IDH1 (R132) and check blood counts and organ function
- Urine/blood test to rule out pregnancy
- Electrocardiogram (ECG) test to measure electrical activity in your heart
- Bone marrow biopsy and aspiration
If some of the tests above have been performed recently, they may not need to be repeated. Your study doctor will determine which tests are needed to confirm eligibility.
What to Expect
If you are eligible for this study, you will be given the drug ivosidenib to take once a day at the same time each time.
The drug is an easy-to-take tablet that can be swallowed with or without food. Doctors will ask that you avoid high-fat meals before and after you take the medication. You also should not drink or eat any grapefruit or grapefruit products, as those can alter the drug’s intended effect.
You will be required to keep a daily diary to record every time you take ivosidenib.
Your local doctor will conduct regular physical exams and continue your normal care. The study team will order additional blood tests and echocardiograms during the entire time you are on the medication and monitor you for side effects. Pregnancy tests also will continue to be done if you are a woman of childbearing potential.
Length of Time in Clinical Trial
Ivosidenib will be given to you for up to 17 months. Your participation may end sooner if you cannot tolerate the drug’s side effects or if your disease becomes worse.
About a month after you complete the last course of medication, you will undergo a final physical exam and have repeat blood tests and an echocardiogram. You may also undergo another bone marrow biopsy and/or aspiration for research purposes.
Risk Factors
Although ivosidenib has been approved for other uses, it is considered an investigational drug for the PIMMs study. Some risks associated with taking the drug include:
- Abnormal electrical activity in your heart or irregular heartbeats
- Swelling in the arms or legs
- Abnormally high white blood cell count
- Unexplained fever
- Shortness of breath
- Fluid build-up around the lungs
- Low blood pressure
- Unexplained weight gain
- Abnormal liver function tests
You can learn more about the potential side effects and risks in the Informed Consent document that must be reviewed and signed before starting the clinical trial. If you enroll in the clinical trial but later change your mind, you can withdraw from participation at any time.
If you would like to learn more and enroll in the PIMMs clinical trial, contact us.