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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

NCT03839771 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 968

Last updated 2024-10-02

No results posted yet for this study

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

Interventions

DRUG

AG-120

250mg tablets

DRUG

Placebo for AG-120

250mg tablets

DRUG

AG-221

100mg tablets

DRUG

Placebo for AG-221

100mg tablets

Sponsors & Collaborators

  • Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)

    collaborator UNKNOWN

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    lead OTHER

Principal Investigators

  • B.J. Wouters · Erasmus MC / HOVON

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2027-04-17
Completion
2034-09-19
FDA Drug
Yes

Countries

  • Australia
  • Austria
  • Belgium
  • Estonia
  • Finland
  • France
  • Germany
  • Ireland
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03839771 on ClinicalTrials.gov