RecruitingPhase 2NCT03683433

Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation

Phase II Study of the Targeted Mutant IDH2 Inhibitor Enasidenib in Combination With Azacitidine for Relapsed/Refractory AML


Sponsor

M.D. Anderson Cancer Center

Enrollment

50 participants

Start Date

Sep 18, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well enasidenib and azacitidine work in treating patients with IDH2 gene mutation and acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). Enasidenib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two drugs — enasidenib (a targeted therapy) and azacitidine (a chemotherapy drug) — in patients with acute myeloid leukemia (AML, a fast-growing blood cancer) whose cancer has a specific gene change called an IDH2 mutation and whose cancer has come back or stopped responding to treatment. **You may be eligible if...** - You have been diagnosed with AML or a related blood cancer that has an IDH2 gene mutation - Your cancer has failed prior treatment, or you are newly diagnosed and over 60 years old and cannot tolerate intensive chemotherapy - You are well enough to carry out some daily activities (performance status 0–3) - Your kidney and liver functions are within acceptable ranges **You may NOT be eligible if...** - Your AML does NOT have an IDH2 mutation - You have been previously treated with enasidenib - You are pregnant or breastfeeding - You have certain serious conditions like uncontrolled infection or severe organ dysfunction - You have active or untreated cancer of the brain or spinal fluid 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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Interventions

DRUGAzacitidine

Given SC or IV

DRUGEnasidenib Mesylate

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03683433


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