RecruitingPhase 2NCT03383575

Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

Targeted Therapy With the IDH2-Inhibitor Enasidenib (AG221) for High-Risk IDH2-Mutant Myelodysplastic Syndrome

Sponsor

M.D. Anderson Cancer Center

Enrollment

63 participants

Start Date

Jan 17, 2018

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Recurrent High Risk Myelodysplastic Syndrome Refractory High Risk Myelodysplastic Syndrome Myelodysplastic Syndrome With Excess Blasts Blasts 20-30 Percent of Bone Marrow Nucleated Cells IDH2 Gene Mutation

Summary

This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining two drugs — azacitidine (a standard treatment for blood disorders) and enasidenib (a targeted therapy) — can help patients with a type of blood disorder called myelodysplastic syndrome (MDS) that carries a specific genetic mutation called IDH2. **You may be eligible if...** - You have been diagnosed with myelodysplastic syndrome (MDS) or a closely related blood condition, confirmed by tissue testing - Your cancer cells carry an IDH2 gene mutation (IDH2-R140 or IDH2-R172), confirmed by a lab test - You have signed informed consent before any study-specific procedures - You meet other health and blood count criteria specified by the study **You may NOT be eligible if...** - Your cancer cells do not carry the IDH2 gene mutation - You have received prior treatment that disqualifies you from one or both treatment arms - Your overall health or organ function does not meet the required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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