# Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy

> **NCT07075016** · PHASE3 · RECRUITING · sponsor: **Stichting Hemato-Oncologie voor Volwassenen Nederland** · enrollment: 227 (estimated)

## Conditions studied

- Acute Myeloid Leukemia

## Interventions

- **DRUG:** Venetoclax 400
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT07075016
- **Lead sponsor:** Stichting Hemato-Oncologie voor Volwassenen Nederland
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-08-05
- **Primary completion:** 2028-12
- **Final completion:** 2029-03
- **Target enrollment:** 227 (ESTIMATED)
- **Last updated:** 2025-08-19

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07075016

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07075016, "Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT07075016. Licensed CC0.

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