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Study Title and Description

Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML.



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 Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML.
Author DiNardo CD., Stein EM., de Botton S., Roboz GJ., Altman JK., Mims AS., Swords R., Collins RH., Mannis GN., Pollyea DA., Donnellan W., Fathi AT., Pigneux A., Erba HP., Prince GT., Stein AS., Uy GL., Foran JM., Traer E., Stuart RK., Arellano ML., Slack JL., Sekeres MA., Willekens C., Choe S., Wang H., Zhang V., Yen KE., Kapsalis SM., Yang H., Dai D., Fan B., Goldwasser M., Liu H., Agresta S., Wu B., Attar EC., Tallman MS., Stone RM., Kantarjian HM.
Country From the University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., H.M.K.); Memorial Sloan Kettering Cancer Center (E.M.S., M.S.T.) and Weill Cornell Medical College (G.J.R.), New York; Institut Gustave Roussy, Villejuif (S.B., C.W.), and Centre Hospitalier Universitaire Bordeaux, Bordeaux (A.P.) - both in France; Northwestern University, Chicago (J.K.A.); Ohio State University Wexner Medical Center, Columbus (A.S.M.); Sylvester Comprehensive Cancer Center, University of Miami, Miami (R.S.); University of Texas Southwestern Medical Center, Dallas (R.H.C.); University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco (G.N.M.), and City of Hope Medical Center, Duarte (A.S.S.) - both in California; University of Colorado School of Medicine, Aurora (D.A.P.); Sarah Cannon Research Institute, Nashville (W.D.); Massachusetts General Hospital Cancer Center (A.T.F.) and Dana-Farber Cancer Institute (R.M.S.), Boston, and Agios Pharmaceuticals, Cambridge (S.C., H.W., V.Z., K.E.Y., S.M.K., H.Y., D.D., B.F., M.G., H.L., S.A., B.W., E.C.A.) - all in Massachusetts; University of Alabama at Birmingham, Birmingham (H.P.E.); Johns Hopkins University, Baltimore (G.T.P.); Washington University School of Medicine, St. Louis (G.L.U.); Mayo Clinic, Jacksonville, FL (J.M.F.); Oregon Health and Science University Knight Cancer Institute, Portland (E.T.); Hollings Cancer Center, Medical University of South Carolina, Charleston (R.K.S.); Winship Cancer Institute of Emory University, Atlanta (M.L.A.); Mayo Clinic, Phoenix, AZ (J.L.S.); and Cleveland Clinic, Cleveland (M.A.S.).
Year 2018
Numbers Pubmed ID: 29860938

Secondary Publication Information
UI Title Author Country Year
Ivosidenib induces deep durable remissions in patients with newly diagnosed IDH1-mutant acute myeloid leukemia. Roboz GJ., DiNardo CD., Stein EM., de Botton S., Mims AS., Prince GT., Altman JK., Arellano ML., Donnellan W., Erba HP., Mannis GN., Pollyea DA., Stein AS., Uy GL., Watts JM., Fathi AT., Kantarjian HM., Tallman MS., Choe S., Dai D., Fan B., Wang H., Zhang V., Yen KE., Kapsalis SM., Hickman D., Liu H., Agresta SV., Wu B., Attar EC., Stone RM. Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, NY. 2020
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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 evaluating the role of Ivosidenib in RR AML. Phase 1/2 study evaluating the role of Ivosidenib in RR AML.
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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 14.8 months (ranges from 0.2-30.3)
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Baseline Characteristics
Question Phase 1/2 study evaluating the role of Ivosidenib in RR AML. Total Comments
AnswerFollow-up AnswerFollow-up
The age of the participants. The median age was 67 years-old. The median age was 67 years-old
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Inclusion Criteria. Patients who received Ivosidenib at dose 500 mg once daily at dose escalation and expansion phase. Who had second or later relapse, who failed induction or reinduction,who had relapse in less than 12 months after the initial therapy,who had relapse after stem cell transplantation. Patients who received Ivosidenib at dose 500 mg once daily at dose escalation and expansion phase. Who had second or later relapse, who failed induction or reinduction,who had relapse in less than 12 months after the initial therapy,who had relapse after stem cell transplantation.
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Characteristics of the genetic mutations in AML patients. 20/179 had MDS. 16/179 had treatment related AML. Intermediate cytogenetics 105/179. Poor cytogenetics 50/179. FLT-3 11/172. NPM1 44/172. CEBPA 4/172. 20/179 had MDS. 16/179 had treatment related AML. Intermediate cytogenetics 105/179. Poor cytogenetics 50/179. FLT-3 11/172. NPM1 44/172. CEBPA 4/172.
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Number of previous lines of chemotherapy/ Percentages of relapse and refractory AML. 127/179 had intensive prior chemotherapy. Relapse after transplant 43/179. Second or later relapse 26/179. Disease that was refractory to initial induction or reinduction 106/179. 127/179 had intensive prior chemotherapy. Relapse after transplant 43/179. Second or later relapse 26/179. Disease that was refractory to initial induction or reinduction 106/179.
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments
Phase 1/2 study evaluating the role of Ivosidenib in RR AML. IDH 7/179
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. QT Prolongation 14/179
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. Anemia 4/179
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. Thrombocytopenia 3/179
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. Leukocytosis 3/179
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. IDH/u 3/34
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. QT Prolongation/u 2/34
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. Thrombocytopenia/u 5/34
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. Leukocytosis/u 1/34
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Phase 1/2 study evaluating the role of Ivosidenib in RR AML. Anemia/u 4/34
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