Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia
TOCIVENA
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
2 other identifiers
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2026
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
March 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 10, 2030
February 17, 2026
January 1, 2026
2.3 years
January 30, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DLT
number of DLT
42 days
Secondary Outcomes (14)
response to treatment
28 months
response to treatment
28 months
Death
48 months
follow - up
48 months
relapse
48 months
- +9 more secondary outcomes
Study Arms (1)
Tocilizumab
EXPERIMENTAL* 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
Interventions
Combining tocilizumab with the standard treatment of azacitidine and venetoclax
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU of Nantes
Nantes, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2026
First Posted
February 6, 2026
Study Start
March 10, 2026
Primary Completion (Estimated)
July 10, 2028
Study Completion (Estimated)
July 10, 2030
Last Updated
February 17, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share