OncoMatch/Clinical Trials/NCT03728335
Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation
Is NCT03728335 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Enasidenib Mesylate for acute myeloid leukemia.
Treatment: Enasidenib Mesylate — This phase II trial studies the side effects of using enasidenib as maintenance therapy in treating patients with acute myeloid leukemia with IDH2 mutation following donor stem cell transplant. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH2 mutation
Performance status
ECOG OR KARNOFSKY 0–2
Prior therapy
Must have received: allogeneic hematopoietic cell transplant
Recipients of allogeneic HCT - all stem cell sources including sibling, unrelated, mismatched related/unrelated, cord and haploidentical transplant patients will be included
Lab requirements
Blood counts
Absolute neutrophil count (ANC) > 1000; Hemoglobin >= 9.5 gm%; Platelets > 50,000/mm^3 or >= 20,000/mm^3 (patients with lower counts can enroll if infection is being treated actively)
Kidney function
Creatinine clearance of >= 40/min/1.73 m^2 for participants with creatinine levels above institutional normal per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 X ULN (unless has Gilbert's disease); Total bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert's Syndrome; AST/ALT <= 2 x ULN, patients with abnormal LFTs in the context of active GVHD will not be included
Cardiac function
Corrected QT (QTc) <= 480 ms
Absolute neutrophil count (ANC) > 1000; Hemoglobin >= 9.5 gm%; Platelets > 50,000/mm^3 or >= 20,000/mm^3 (patients with lower counts can enroll if infection is being treated actively); Total bilirubin <= 1.5 X ULN (unless has Gilbert's disease); Total bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert's Syndrome; AST/ALT <= 2 x ULN, patients with abnormal LFTs in the context of active GVHD will not be included; Creatinine clearance of >= 40/min/1.73 m^2 for participants with creatinine levels above institutional normal per 24 hour urine test or the Cockcroft-Gault formula; Corrected QT (QTc) <= 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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