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Not yet recruiting NCT07392814

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

Phase I Interventional Leukemia Acute Myeloid - AML

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: increase dose of tocilizumab.
Who it may be relevant to
Registry conditions: Leukemia Acute Myeloid - AML. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • DLT [Time frame: 42 days]
Secondary outcome measures (12)
  • response to treatment [Time frame: 28 months]
  • response to treatment [Time frame: 28 months]
  • Death [Time frame: 48 months]
  • follow - up [Time frame: 48 months]
  • relapse [Time frame: 48 months]
  • death [Time frame: 48 months]
  • follow up [Time frame: 48 months]
  • relapse [Time frame: 48 months]
  • relapse [Time frame: 48 months]
  • neutrophil [Time frame: 48 months]
  • platelets [Time frame: 48 months]
  • infection [Time frame: 48 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU of Nantes — Nantes

Identifiers

NCT: NCT07392814 · RC25_0533 · 2025-524725-41-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗