NCT07392814Not yet recruitingPhase 1
Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia
Single-Center Phase 1 Study With Escalating Doses of Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia (AML). TOCIVENA
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy. The patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- 10 Mar 2026
- Primary completion date
- 10 Jul 2028
- Lead sponsor
- Nantes University Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07392814
- EU CT number
- 2025-524725-41-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 10 Mar 2026 to the primary completion date, 10 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled infection
- Active and/or treated infection with Hep B, C, or HIV
- Hypersensitivity to any of the active substances or excipients (see SPCs)
Other
- LAM3
- Patients eligible for intensive "3+7" treatment
- No social security or other health insurance
- Pregnant women or patients who cannot use contraception due to fertility
- Breastfeeding women
- Minors
- Adults under guardianship, conservatorship, or legal protection
- Patients unable to understand spoken or written French
Who the study is looking for
- First-line AML regardless of karyotype and molecular profile
- ECOG \<= 3
- Patient eligible for chemotherapy combining azacitidine and venetoclax
- Informed consent
- Liver function tests: transaminases \< 3x normal, bilirubin \< 1.5x normal
- Creatinine clearance \> 30 ml/min
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU of Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.