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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Leukemia Acute Myeloid - AML
• Intervention / Treatment: Drug: increase dose of tocilizumab

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Peterlin Pierre; Phone Number: +33 02 40 08 74 018; Email: pierre.peterlin@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44000
    • CHU of Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tocilizumab; 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	Drug: increase dose of tocilizumab; Combining tocilizumab with the standard treatment of azacitidine and venetoclax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT	number of DLT	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response to treatment	number of response	28 months
response to treatment	number of response without detectable residual disease	28 months
Death	number of days between Day 1 and Death	48 months
follow - up	number of days between Day 1 and follow - up date	48 months
relapse	number of days between remission day 1 and relapse	48 months
death	number of days between remission and death	48 months
follow up	number of days between remission and follow - up date	48 months
relapse	number of days between remission and relapse	48 months
relapse	number of relapse	48 months
neutrophil	number of days of neutrophil recovery	48 months
platelets	number of days of platelets recovery	48 months
infection	number of infection	48 months
cytokine	number of cytokine	48 months
tocilizumab	number of tocilizumab	48 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2026
• Primary Completion (Estimated): July 10, 2028
• Study Completion (Estimated): July 10, 2030

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Leukemia; tocilizumab; IL6
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia
• Other Study ID Numbers: RC25_0533; 2025-524725-41-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No