# 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** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Stichting Hemato-Oncologie voor Volwassenen Nederland** · enrollment: 968 (estimated)

## Conditions studied

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

## Interventions

- **DRUG:** AG-120
- **DRUG:** Placebo for AG-120
- **DRUG:** AG-221
- **DRUG:** Placebo for AG-221

## Key facts

- **NCT ID:** NCT03839771
- **Lead sponsor:** Stichting Hemato-Oncologie voor Volwassenen Nederland
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2019-03-01
- **Primary completion:** 2027-04-17
- **Final completion:** 2034-09-19
- **Target enrollment:** 968 (ESTIMATED)
- **Last updated:** 2024-10-02

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03839771

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT03839771. Licensed CC0.

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