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Clinical Trials in France / NCT07392814
Starting soon Phase 1

Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia

NCT07392814 · tracked via the Priya Life Science France tracker
Sponsor
Nantes University Hospital
Phase
Phase 1
Started
2026-03-10
Last updated
2026-02-17

Condition(s) studied

Leukemia Acute Myeloid - AML

Investigational drug(s) / intervention(s)

increase dose of tocilizumab

increase dose of tocilizumab: Combining tocilizumab with the standard treatment of azacitidine and venetoclax

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • DLT — 42 days
    number of DLT

Trial sites (1)

FacilityCityRegionStatus
CHU of Nantes Nantes France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07392814 on ClinicalTrials.gov ↗ ← All trials in France