AN OPEN-LABEL FEASIBILITY STUDY TO ASSESS THE SAFETY AND PHARMACOKINETICS OF ENASIDENIB IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (R/R-AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION

Study category: Cancer

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Description

The overall goals of this study are to: - Find out what effects, good and/or bad, enasidenib has on people with your AML cancer and IDH2 mutation. - To learn more about the side effects of enasidenib The study of enasidenib in children and young adults with AML is investigational. This study is a ‘feasibility’ study, meaning that results from the study may be incorporated into future treatment plans.

Details
Age

Child

Eligibility

- Patients must be ≥ 24 months and ≤ 18 years of age at the time of study enrollment. - Patient must have AML with an IDH2 mutation identified from a peripheral blood or bone marrow sample at the time of diagnosis and/or relapsed/refractory disease. - Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.

Type of Study

Treatment

Locations

Childrens Hospital Colorado

Principal Investigator
Margaret Macy,  MD

Margaret Macy, MD

Study ID

Protocol Number: 20-3065

More information available at ClinicalTrials.gov: NCT04203316

Categories

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