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NCT Number: NCT07392814

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

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.

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Key information

Conditions

Leukemia Acute Myeloid - AML Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU of Nantes

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

increase dose of tocilizumab

Drug

Combining tocilizumab with the standard treatment of azacitidine and venetoclax

Primary outcomes

  1. DLT

    Time frame: 42 days

    number of DLT

Secondary outcomes

  1. response to treatment

    Time frame: 28 months

    number of response

  2. response to treatment

    Time frame: 28 months

    number of response without detectable residual disease

  3. Death

    Time frame: 48 months

    number of days between Day 1 and Death

  4. follow - up

    Time frame: 48 months

    number of days between Day 1 and follow - up date

  5. relapse

    Time frame: 48 months

    number of days between remission day 1 and relapse

  6. death

    Time frame: 48 months

    number of days between remission and death

  7. follow up

    Time frame: 48 months

    number of days between remission and follow - up date

  8. relapse

    Time frame: 48 months

    number of days between remission and relapse

  9. relapse

    Time frame: 48 months

    number of relapse

  10. neutrophil

    Time frame: 48 months

    number of days of neutrophil recovery

  11. platelets

    Time frame: 48 months

    number of days of platelets recovery

  12. infection

    Time frame: 48 months

    number of infection

  13. cytokine

    Time frame: 48 months

    number of cytokine

  14. tocilizumab

    Time frame: 48 months

    number of tocilizumab

Study contacts

Contact information is provided by the study sponsor or research team.

Peterlin Pierre

CONTACT

[email protected]

02 40 08 74 018 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: TOCIVENA

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Feb 6, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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