Date trial registered
Incorporation of the first participant
Academic title (Source of data: WHO)
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy.
Type of trial (Source of data: WHO)
Design of the trial (Source of data: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
Phase (Source of data: WHO)
Primary end point (Source of data: WHO)
Event-free survival (EFS)
Secundary end point (Source of data: WHO)
Complete remission without minimal residual disease (CRMRD-) rate after induction cycle 2
CR/CRi rate after remission induction (i.e., CR or CRi as best response during or at completion of induction therapy)
CR/CRi rates after induction cycle 1 and 2
Cumulative incidence of death (CID) after CR/CRi
Cumulative incidence of relapse (CIR) after CR/CRi
EORTC-QLQ-C30 global health status/QoL scale.
EQ-5D-5L visual analogue scale (VAS)
Frequency and severity of adverse events according to CTCAE version 5.0
Overall survival (OS)
Relapse-free survival (RFS) after CR/CRi
Time to hematopoietic recovery after each chemotherapy treatment cycle
Contact information (Source of data: WHO)
Please refer to primary and secondary sponsors