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Study Title and Description

Enasidenib in mutant



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 in mutant
Author Stein EM., DiNardo CD., Pollyea DA., Fathi AT., Roboz GJ., Altman JK., Stone RM., DeAngelo DJ., Levine RL., Flinn IW., Kantarjian HM., Collins R., Patel MR., Frankel AE., Stein A., Sekeres MA., Swords RT., Medeiros BC., Willekens C., Vyas P., Tosolini A., Xu Q., Knight RD., Yen KE., Agresta S., de Botton S., Tallman MS.
Country Memorial Sloan Kettering Cancer Center, New York, NY.
Year 2017
Numbers Pubmed ID: 28588020

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. 113 subjects in the dose escalation phase and 126 subjects in the 4 arm dose expansion phase of the study.
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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 7.7 months (ranges between 0.4-26.7 months). The median number of Enasidenib cycles was 5 (ranges from 1-25 cycles)
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Baseline Characteristics
Question Phase 1/2 study. Total Comments
AnswerFollow-up AnswerFollow-up
The age of the participants. The median age was 70 years-old of the 239 subjects who had RR AML (including all doses). Median age of 70 years-old.
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Inclusion Criteria. 18 years and older, who had advanced Acute Myeloid Leukemia, ECOG score of 0-2 and harbor IDH mutation, AML or MDS with refractory anemia and excess blast. 18 years and older, who had advanced Acute Myeloid Leukemia, ECOG score of 0-2 and harbor IDH mutation, AML or MDS with refractory anemia and excess blast.
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Characteristics of the genetic mutations in AML patients. Out of total 239 subjects, 117 had intermediate Cytogenetics risk status (67%) and 58 (33%) had poor Cytogenetics risk status. 17 patients had NPM1 gene mutation, CEBPA mutation found in 10 patients while FLT3-ITD found in 4 subjects. Antecedent history of MDS in 30 subjects and 28 subjects had prior stem cell transplantation. 179/239 had RI40 mutation, while 57/239 had RI72 mutation. 176/239 patients had RR AML and constitutes our primary interest in our meta-analysis.
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Number of previous lines of chemotherapy/ Percentages of relapse and refractory AML. 176 patients had RR AML. 43 subjects relapsed after 2 or more cycles, 41 relapsed within 1 year of initial treatment, 24 relapsed after transplant, 22 had second or more relapses and 15 relapsed after 1 year. 176 patients had RR AML. 43 subjects relapsed after 2 or more cycles, 41 relapsed within 1 year of initial treatment, 24 relapsed after transplant, 22 had second or more relapses and 15 relapsed after 1 year.
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments
Phase 1/2 study. Hyperbilirubinemia 29/239
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Phase 1/2 study. DS 15/239
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Phase 1/2 study. Anemia 12/239
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Phase 1/2 study. Thrombocytopenia 15/239
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Phase 1/2 study. TLS 8/239
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Phase 1/2 study. Decrease appetite 6/239
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Phase 1/2 study. Leukocytosis 6/239
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Phase 1/2 study. Fatigue 6/239
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Phase 1/2 study. Nausea 5/239
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Phase 1/2 study. Lipase increase 5/239
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