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Study Title and Description

Enasidenib, an inhibitor of mutant IDH2 proteins, induces durable remissions in older patients with newly diagnosed acute myeloid leukemia.



Key Questions Addressed
1 What are the Objective response rates (ORR), Complete remission rates (CR) among AML patients who had received IDH inhibitors.
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2 What are the main treatment emergent adverse events that are associated with IDH inhibitors.
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Primary Publication Information
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TitleData
Title Enasidenib, an inhibitor of mutant IDH2 proteins, induces durable remissions in older patients with newly diagnosed acute myeloid leukemia.
Author Pollyea DA., Tallman MS., de Botton S., Kantarjian HM., Collins R., Stein AS., Frattini MG., Xu Q., Tosolini A., See WL., MacBeth KJ., Agresta SV., Attar EC., DiNardo CD., Stein EM.
Country Division of Hematology, University of Colorado School of Medicine, Aurora, CO, USA. daniel.pollyea@ucdenver.edu.
Year 2019
Numbers Pubmed ID: 30967620

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Phase 1 and 2 trials that looked at the effect of IDH inhibitors in AML patients.
Arms
Number Title Description Comments
1 Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction.
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Design Details
Question... Follow Up Answer Follow-up Answer
Duration of the study and its median follow up time. Median follow up time of 8.4 months.
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Baseline Characteristics
Question Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. Total Comments
AnswerFollow-up AnswerFollow-up
The age of the participants. 77 years-old
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Inclusion Criteria. Elderly AML patients who were not candidate for traditional chemotherapy induction. Elderly AML patients who were not candidate for traditional chemotherapy induction.
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Characteristics of the genetic mutations in AML patients. 10/39 had poor cytogenetics as per NCCN guidelines. 10/39 had poor cytogenetics as per NCCN guidelines.
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Number of previous lines of chemotherapy/ Percentages of relapse and refractory AML. 23/39 had antecedent hematological disorder including MDS, CMML, Myelofibrosis and Polycythemia Rubra Vera. 23/39 had antecedent hematological disorder including MDS, CMML, Myelofibrosis and Polycythemia Rubra Vera
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments
Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. Indirect hyperbilirubinemia. 5/39
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Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. Anemia 5/39
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Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. IDH 4/39
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Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. Thrombocytopenia 3/39
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Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. TLS 3/39
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Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. Leukopenia 2/39
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Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. Cytopenia 8/39
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Phase 1/2 study looking at the effect of Enasidenib in elderly patients who are not candiate for tranditional AML induction. Pneumonia 7/39
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