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NCT07007949
a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia
Phase 2 trial testing Ivosidenib combined with venetoclax and azacitidine in Acute Myeloid Leukemia in 42 participants. Currently enrolling.
30 April 2026
Quick facts
| Lead sponsor | The First Affiliated Hospital of Soochow University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 June 2025 |
| Primary completion | 30 April 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Ivosidenib combined with venetoclax and azacitidine — full drug profile →
- Ivosidenib combined with venetoclax and azacitidine — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- IDH1 Gene Mutation — all drugs for IDH1 Gene Mutation →
- Ivosidenib — all drugs for Ivosidenib →
Sponsor
The First Affiliated Hospital of Soochow University
Who can join
18 and older, any sex, with Acute Myeloid Leukemia or IDH1 Gene Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of ivosidenib+venetoclax+ azacitidine in adult Chinese subjects with newly diagnosed IDH1m AML.A total of approximately 42 China Nationwide subjects with newly diagnosed IDH1m AML will participate in the study.The primary endpoint of the study is the complete remission(CR) + CR with partial hematologic recovery(CRh) rate, and the key secondary endpoints are CR rate,event-free survival (EFS),overall survival (OS),the objective response rate (ORR).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07007949
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Myeloid Leukemia
Currently open trials in the same condition.
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Other The First Affiliated Hospital of Soochow University trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07007949 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University
- Last refreshed: 6 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07007949.
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