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

StatusRecruiting
PhasePhase 2
Started2018-09-18
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
2 amendments v11-v12
2 re-verifications since 2026-03-03, no change to tracked fields
2025-09-08
Study Status v10
Primary completion date2025-09-20→2027-09-20
Completion date2025-09-20→2027-09-20
2025-08-12
4 amendments v6-v9
4 re-verifications since 2024-02-20, no change to tracked fields
2023-08-15
Study Status v5
Primary completion date2023-09-20→2025-09-20
Completion date2023-09-20→2025-09-20
2022-12-05
Study Status v4
Primary completion date2022-09-20→2023-09-20
Show 3 earlier versions
2022-05-09
Study Identification, Study Status v3
Primary completion date2021-09-20→2022-09-20
Completion date2021-09-20→2023-09-20
2019-08-14
Study Status, Study Description, Arms and Interventions, Contacts/Locations v2
Study description-1 characters
[...] ib mesylate orally (PO) once daily (QD) beginning on day 1. CoursesCycles repeat every 4-6 weeks in the absence of disease progressio [...]
Study sitescontacts updated at 1 of 1 site
2018-11-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2021-09-30→2021-09-20
Completion date2021-09-30→2021-09-20
Start dateestimated 2019-02-28→confirmed 2018-09-18
Study sitesdetails revised at 1 of 1 site
2018-09-21
Original filing
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.
Trial Details
NCT Number NCT03683433
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Acute Bilineal Leukemia, Acute Biphenotypic Leukemia, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Enrollment 50 participants
Start Date 2018-09-18
Primary Completion 2027-09-20 (estimated)
Study Completion 2027-09-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-14