NCT03839771

A 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 Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

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.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 968 (estimated)
• Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome With Excess Blasts-2

Interventions

Type	Name	Description
DRUG	AG-120	250mg tablets
DRUG	Placebo for AG-120	250mg tablets
DRUG	AG-221	100mg tablets
DRUG	Placebo for AG-221	100mg tablets

Timeline

• Start date: 2019-03-01
• Primary completion: 2027-04-17
• Completion: 2034-09-19
• First posted: 2019-02-15
• Last updated: 2024-10-02

Locations

181 sites across 15 countries: Australia, Austria, Belgium, Estonia, Finland, France, Germany, Ireland, Lithuania, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland

Regulatory

• FDA-regulated drug study