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Study Title and Description

Molecular remission and response patterns in patients with 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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Primary Publication Information
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TitleData
Title Molecular remission and response patterns in patients with mutant-
Author Stein EM., DiNardo CD., Fathi AT., Pollyea DA., Stone RM., Altman JK., Roboz GJ., Patel MR., Collins R., Flinn IW., Sekeres MA., Stein AS., Kantarjian HM., Levine RL., Vyas P., MacBeth KJ., Tosolini A., VanOostendorp J., Xu Q., Gupta I., Lila T., Risueno A., Yen KE., Wu B., Attar EC., Tallman MS., de Botton S.
Country Memorial Sloan Kettering Cancer Center, New York, NY.
Year 2019
Numbers Pubmed ID: 30510081

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. 345 patients were recruited from 21 sites and had received more than one dose of Enasidenib. 280 patients with RR AML had received doses ranges from 50-650 mg with 214 patients had recieved 100 mg dose.
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Design Details
Question... Follow Up Answer Follow-up Answer
Duration of the study and its median follow up time. The median follow up time is 7.8 months. The median number of Enasidenib was 5 (1-38)
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Baseline Characteristics
Question Phase 1/2 study. Total Comments
AnswerFollow-up AnswerFollow-up
The age of the participants. Median age of 68 years-old Median age of 68 years-old
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Inclusion Criteria. Adults more than 18 years-old, with mutant IDH-2, who had relapse after allogenic stem cell transplant, had experienced 2 or more relapses, were refractory to initial induction or reinduction treatment, or had relapsed within 1 year of the initial treatment, excluding those with favorable risk factors. Adults more than 18 years-old, with mutant IDH-2, who had relapse after allogenic stem cell transplant, had experienced 2 or more relapses, were refractory to initial induction or reinduction treatment, or had relapsed within 1 year of the initial treatment, excluding those with favorable risk factors.
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Characteristics of the genetic mutations in AML patients. Out of the 280 subjects who had RR AML. 141/280 were intermediate risk. 69/280 were poor risk. 70/280 were missing. MDS related changes 63/280. Recurrent genetic abnormalities 36/280. Therapy related myeloid neoplasms 6/280. RI 40 209/280. RI 72 70/280. Out of the 280 subjects who had RR AML. 141/280 were intermediate risk. 69/280 were poor risk. 70/280 were missing. MDS related changes 63/280. Recurrent genetic abnormalities 36/280. Therapy related myeloid neoplasms 6/280. RI 40 209/280. RI 72 70/280.
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Number of previous lines of chemotherapy/ Percentages of relapse and refractory AML. 1, 125/280. 2, 82/280. >=3, 73/280. 1, 125/280. 2, 82/280. >=3, 73/280.
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments
Phase 1/2 study.
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