Clinical trial
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.
NCT03839771 is registered in ClinicalTrials.gov with Stichting Hemato-Oncologie voor Volwassenen Nederland as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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.
- Lead sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Phase
- Phase 3
- Overall status
- Active, not recruiting
- Start date
- March 1, 2019
- Completion date
- September 19, 2034
- Enrollment
- 968 (estimated)
- Sites
- 181
Conditions
As the registry lists them; a condition with its own page is linked.
acute myeloid leukemia, myelodysplastic syndrome with excess blasts-2