Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia Acute Myeloid - AML | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| increase dose of tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tocilizumab
- description
- * Level 1: 4 mg/kg on Day 1 of cycles 1 to 3 * Level 2: 6 mg/kg on Day 1 of cycles 1 to 3 (starting dose for the first cohort) * Level 3: 8 mg/kg on Day 1 of cycles 1 to 3 * Level 4: 4 mg/kg on Days 1 and 15 of cycles 1 to 3
- interventionNames
- Drug: increase dose of tocilizumab
Primary outcomes (1)
- measure
- DLT
- timeFrame
- 42 days
- description
- number of DLT
Secondary outcomes (14)
- measure
- response to treatment
- timeFrame
- 28 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * LAM3 * Patients eligible for intensive "3+7" treatment * Uncontrolled infection * Active and/or treated infection with Hep B, C, or HIV * 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 * Hypersensitivity to any of the active substances or excipients (see SPCs) * Patients unable to understand spoken or written French
References
Publications (0)
Data not yet available