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NCT07117422
Venetoclax-Decitabine in Untreated Elderly/Unfit AML
NA trial testing VEN + DEC in AML, Adult in 39 participants. Currently enrolling.
30 January 2026
Quick facts
| Lead sponsor | The Second Hospital of Hebei Medical University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 17 January 2025 |
| Primary completion | 30 January 2026 |
| Estimated completion | 30 January 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- VEN + DEC — full drug profile →
Conditions studied
- AML, Adult — all drugs for AML, Adult →
Sponsor
The Second Hospital of Hebei Medical University
Who can join
65 and older, any sex, with AML, Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Acute myeloid leukemia (AML) is a highly fatal malignancy in China, with particularly poor outcomes in elderly patients. Low-intensity regimens yield low remission rates, and median overall survival (OS) typically remains under 6-9 months. Venetoclax (VEN) combined with hypomethylating agents (azacitidine or decitabine（DEC）) has emerged as a first-line therapy for these patients, significantly improving response rates and survival. However, challenges persist, including suboptimal complete remission (CR) rates, low Measurable Residual Disease（MRD） negativity, and tolerability issues with prolonged use. Recent studies suggest that a 3-day decitabine regimen combined with VEN may enhance efficacy and tolerability. Building on prior evidence and our institutional experience, we propose this study to evaluate an optimized dosing strategy of VEN plus decitabine in treatment-naïve elderly or chemotherapy-ineligible AML patients, aiming to further improve clinical outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07117422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT07117422 (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 Second Hospital of Hebei Medical University
- Last refreshed: 12 August 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/NCT07117422.
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