{"NCTID":"NCT03683433","clinicalTrial":{"derivedSection":{"conditionBrowseModule":{"ancestors":[{"id":"D007945","term":"Leukemia, Lymphoid"},{"id":"D007938","term":"Leukemia"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009369","term":"Neoplasms"},{"id":"D006402","term":"Hematologic Diseases"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"},{"id":"D008232","term":"Lymphoproliferative Disorders"},{"id":"D008206","term":"Lymphatic Diseases"},{"id":"D007160","term":"Immunoproliferative Disorders"},{"id":"D007154","term":"Immune System Diseases"},{"id":"D007951","term":"Leukemia, Myeloid"},{"id":"D054437","term":"Myelodysplastic-Myeloproliferative Diseases"},{"id":"D001855","term":"Bone Marrow Diseases"},{"id":"D002908","term":"Chronic Disease"},{"id":"D020969","term":"Disease Attributes"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}],"meshes":[{"id":"D015456","term":"Leukemia, Biphenotypic, Acute"},{"id":"D015477","term":"Leukemia, Myelomonocytic, Chronic"},{"id":"D009190","term":"Myelodysplastic Syndromes"},{"id":"D015470","term":"Leukemia, Myeloid, Acute"}]},"interventionBrowseModule":{"ancestors":[{"id":"D001372","term":"Aza Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D003562","term":"Cytidine"},{"id":"D011741","term":"Pyrimidine Nucleosides"},{"id":"D011743","term":"Pyrimidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D009705","term":"Nucleosides"},{"id":"D009706","term":"Nucleic Acids, Nucleotides, and Nucleosides"},{"id":"D012263","term":"Ribonucleosides"},{"id":"D020005","term":"Propanols"},{"id":"D000438","term":"Alcohols"}],"meshes":[{"id":"D001374","term":"Azacitidine"},{"id":"D019840","term":"2-Propanol"},{"id":"C045880","term":"methanesulfonic acid"},{"id":"C000605269","term":"enasidenib"}]},"miscInfoModule":{"versionHolder":"2026-03-19"}},"hasResults":false,"protocolSection":{"armsInterventionsModule":{"armGroups":[{"description":"Patients receive azacitidine SC or IV over 30 minutes on days 1-7 and enasidenib mesylate PO QD beginning on day 1.\nCycles repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.","interventionNames":["Drug: Azacitidine","Drug: Enasidenib Mesylate"],"label":"Treatment (azacitidine, enasidenib mesylate)","type":"EXPERIMENTAL"}],"interventions":[{"armGroupLabels":["Treatment (azacitidine, enasidenib mesylate)"],"description":"Given SC or IV","name":"Azacitidine","otherNames":["5 AZC","5-AC","5-Azacytidine","5-AZC","Azacytidine","Azacytidine, 5-","Ladakamycin","Mylosar","U-18496","Vidaza"],"type":"DRUG"},{"armGroupLabels":["Treatment (azacitidine, enasidenib mesylate)"],"description":"Given PO","name":"Enasidenib Mesylate","otherNames":["2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate","2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1)","AG-221 Mesylate","CC-90007","Enasidenib Methanesulfonate","Idhifa"],"type":"DRUG"}]},"conditionsModule":{"conditions":["Acute Bilineal Leukemia","Acute Biphenotypic Leukemia","Chronic Myelomonocytic Leukemia","IDH2 Gene Mutation","Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia"]},"contactsLocationsModule":{"centralContacts":[{"email":"cdinardo@mdanderson.org","name":"Courtney DiNardo","phone":"713-794-1141","role":"CONTACT"}],"locations":[{"city":"Houston","contacts":[{"name":"Courtney DiNardo","phone":"713-794-1141","role":"CONTACT"},{"name":"Courtney DiNardo","role":"PRINCIPAL_INVESTIGATOR"}],"country":"United States","facility":"M D Anderson Cancer Center","geoPoint":{"lat":29.76328,"lon":-95.36327},"state":"Texas","status":"RECRUITING","zip":"77030"}],"overallOfficials":[{"affiliation":"M.D. Anderson Cancer Center","name":"Courtney DiNardo","role":"PRINCIPAL_INVESTIGATOR"}]},"descriptionModule":{"briefSummary":"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).\nEnasidenib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.","detailedDescription":"

PRIMARY OBJECTIVES:

I. To determine the clinical activity of enasidenib mesylate (AG221, IDHIFA) in combination with azacitidine (AZA) for patients with relapsed/refractory acute myeloid leukemia is measured by overall response rate (ORR).

SECONDARY OBJECTIVES:

I. To determine duration of response, event-free survival (EFS), and overall survival (OS).

II.\nTo determine the safety of enasidenib in combination with azacitidine in patients with relapsed/refractory acute myeloid leukemia (AML).

EXPLORATORY OBJECTIVES:

I. To evaluate occurrence of minimal residual disease (MRD) negative status by IDH2 mutation analysis and flow cytometry.

II.\nTo investigate possible relationships between baseline protein and gene expression signatures and mutation profile and clinical response to the combination.

III.\nTo evaluate the incidence and characteristics of IDH-inhibitor related differentiation syndrome (IDH-DS) with combination therapy.

OUTLINE:

Patients receive azacitidine subcutaneously (SC) or intravenously (IV) over 30 minutes on days 1-7 and enasidenib mesylate orally (PO) once daily (QD) beginning on day 1.\nCycles repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3-6 months for up to 5 years.

"},"designModule":{"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","maskingInfo":{"masking":"NONE"},"primaryPurpose":"TREATMENT"},"enrollmentInfo":{"count":50,"type":"ESTIMATED"},"phases":["PHASE2"],"studyType":"INTERVENTIONAL"},"eligibilityModule":{"eligibilityCriteria":"

Inclusion Criteria:

Patients with AML or biphenotypic or bilineage leukemia (including a myeloid component) who have failed prior therapy.\nPatients with isolated extramedullary AML are eligible.\nThe World Health Organization (WHO) classification will be used for AML
Elderly (> 60 years old) patients with newly diagnosed AML not eligible for intensive chemotherapy are also eligible
AML patients with prior history of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) regardless of prior therapy received, are eligible at the time of diagnosis of AML
Subjects must have documented IDH2 gene mutation
Eastern Cooperative Oncology Group (ECOG) performance status =< 3
Adequate renal function including creatinine < 2 unless related to the disease
Total bilirubin < 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 3 x ULN unless considered due to leukemic involvement
Provision of written informed consent
Oral hydroxyurea and/or cytarabine (up to 2 g/m2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the principal investigator (PI).\nConcurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment.\nMales must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment

Exclusion Criteria:

Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British [FAB] class M3-AML)
Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, clinically significant and uncontrolled arrhythmia as judged by the treating physician
Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator
Pregnant or breastfeeding

","healthyVolunteers":false,"minimumAge":"18 Years","sex":"ALL","stdAges":["ADULT","OLDER_ADULT"]},"identificationModule":{"briefTitle":"Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation","nctId":"NCT03683433","officialTitle":"Phase II Study of the Targeted Mutant IDH2 Inhibitor Enasidenib in Combination With Azacitidine for Relapsed/Refractory AML","orgStudyIdInfo":{"id":"2018-0499"},"organization":{"class":"OTHER","fullName":"M.D. Anderson Cancer Center"},"secondaryIdInfos":[{"domain":"CTRP (Clinical Trial Reporting Program)","id":"NCI-2018-01919","type":"REGISTRY"},{"domain":"M D Anderson Cancer Center","id":"2018-0499","type":"OTHER"}]},"outcomesModule":{"otherOutcomes":[{"description":"MRD negative status and exploratory biomarkers will be summarized graphically and with descriptive statistics.","measure":"Minimal residual disease (MRD)","timeFrame":"Up to 5 years"},{"description":"Association between molecular and cellular markers and overall response and/or resistance assessed through logistic regression analyses.","measure":"Association of biomarkers to overall response","timeFrame":"Up to 5 years"},{"description":"Paired t-test or Wilcoxon signed rank test will be used to assess the marker change over time.","measure":"Change in markers over time","timeFrame":"Baseline up to 5 years"}],"primaryOutcomes":[{"description":"The study will estimate the ORR for the combination treatment, along with the Bayesian 95% credible interval.\nORR will be defined as the proportion of patients who had CR (complete remission), CRh (complete remission with incomplete hematologic recovery), CRi (complete remission with incomplete count recovery), PR (partial response), and/or marrow clearance of blasts (MLFS).","measure":"Overall response rate (ORR)","timeFrame":"Up to 5 years"}],"secondaryOutcomes":[{"description":"Kaplan-Meier method will be used to estimate the probabilities of event-free survival.","measure":"Event-free survival","timeFrame":"Up to 5 years"},{"description":"Kaplan-Meier method will be used to estimate the probabilities of overall survival.","measure":"Overall survival (OS)","timeFrame":"Up to 5 years"},{"description":"Log-rank tests will be used to compare among subgroups of patients in terms of DFS or OS.","measure":"Disease-free survival (DFS)","timeFrame":"Up to 5 years"},{"description":"Log-rank tests will be used.","measure":"Duration of response","timeFrame":"Up to 5 years"},{"measure":"Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0","timeFrame":"Up to 5 years"}]},"oversightModule":{"isFdaRegulatedDevice":false,"isFdaRegulatedDrug":true,"oversightHasDmc":false},"referencesModule":{"references":[{"citation":"Venugopal S, Takahashi K, Daver N, Maiti A, Borthakur G, Loghavi S, Short NJ, Ohanian M, Masarova L, Issa G, Wang X, Carlos BR, Yilmaz M, Kadia T, Andreeff M, Ravandi F, Konopleva M, Kantarjian HM, DiNardo CD. Efficacy and safety of enasidenib and azacitidine combination in patients with IDH2 mutated acute myeloid leukemia and not eligible for intensive chemotherapy. Blood Cancer J. 2022 Jan 25;12(1):10. doi: 10.1038/s41408-021-00604-2.","pmid":"35078972","type":"DERIVED"}],"seeAlsoLinks":[{"label":"MD Anderson Cancer Center Website","url":"http://www.mdanderson.org"}]},"sponsorCollaboratorsModule":{"collaborators":[{"class":"NIH","name":"National Cancer Institute (NCI)"}],"leadSponsor":{"class":"OTHER","name":"M.D. Anderson Cancer Center"},"responsibleParty":{"type":"SPONSOR"}},"statusModule":{"completionDateStruct":{"date":"2027-09-20","type":"ESTIMATED"},"expandedAccessInfo":{"hasExpandedAccess":false},"lastUpdatePostDateStruct":{"date":"2026-03-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-03-03","overallStatus":"RECRUITING","primaryCompletionDateStruct":{"date":"2027-09-20","type":"ESTIMATED"},"startDateStruct":{"date":"2018-09-18","type":"ACTUAL"},"statusVerifiedDate":"2026-03","studyFirstPostDateStruct":{"date":"2018-09-25","type":"ACTUAL"},"studyFirstSubmitDate":"2018-09-19","studyFirstSubmitQcDate":"2018-09-21"}}},"labeledClinicalTrialsCriteria":{"data":{"criteriaTree":{"id":"root","items":[{"id":"inclusion","items":[{"data":{"hasManualMappings":false,"mappings":[{"_type":"DocumentReference","path":"apps/curehub/conditionMappings/91861009"}],"matchedTerm":"Acute myeloid leukemia","negate":false,"operator":"INCLUDES_OR","relevantText":"Patients with AML or biphenotypic or bilineage leukemia (including a myeloid component) who have failed prior therapy. 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