At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 50 target
Drug / intervention
Azacitidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of the Targeted Mutant IDH2 Inhibitor Enasidenib in Combination With Azacitidine for Relapsed/Refractory AML
In Brief
A Phase 2 clinical trial evaluating Azacitidine and Enasidenib Mesylate for Acute Bilineal Leukemia and 6 related conditions. Currently recruiting, targeting 50 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Bilineal Leukemia, Acute Biphenotypic Leukemia, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2Recruiting
201920202021202220232024202520262027
Enrollment StartSep 2018
First PostedSep 2018
TodayJul 2026
Primary CompletionSep 2027
First PostedSep 25, 2018
Enrollment StartSep 18, 2018
Primary CompletionSep 20, 2027
TodayJul 1, 2026
Enrollment to primary: 9.0 yearsPosted 7.8 years agoPrimary completion in 1.2 years
Interventions
Azacitidinedrug
Given SC or IV
Enasidenib Mesylatedrug
Given PO