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Completed

NCT Number: NCT04547062

Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML)

This is a phase 1 dose escalation study testing the addition of an anti-IL6 (tocilizumab) to standard induction chemotherapy for high-risk AML.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute 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, 44093, France

About this study

Administration of tocilizumab at day 8 of induction following a classical induction using idarubicin 8mg/m2/d for 5 days and cytarabine 100mg/m2/d for 7 days.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AML with a poor prognosis defined according to the criteria below: LAM First line: Age <60 years and unfavorable risk according to the 2017 ELN Age> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the age
  • ECOG <= 2
  • Patient eligible for intensive chemotherapy
  • Informed consent
  • Liver function tests: transaminases <3x normal, bilirubin <1.5X normal
  • Creatinine clearance> 60ml / min
  • LVEF> = 50%

Exclusion criteria

  • Uncontrolled infection
  • Hep B, C, HIV +
  • History of diverticulosis / diverticulitis
  • No social security or any other scheme
  • Pregnant women or patient unable to take contraception(contraceptive pill, abstinence, IUD unauthorized) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last injection of TOCILIZUMAB is not eligible.
  • Lactating women
  • Minors
  • Adults under guardianship, curatorship or legal protection
  • Hypersensitivity to one of the active substances or to one of the excipients
  • Patients with tuberculosis
  • Patients documented with active COVID

Treatment and study plan

Tocilizumab

Drug

Administration of tocilizumab at day 8 of induction following a classical induction

Primary outcomes

  1. number of DLT

    Time frame: 45 days

Secondary outcomes

  1. Number of response

    Time frame: 25 months

  2. Percentage of medullary blaste

    Time frame: 24 months

  3. number of days of neutrophil recovery

    Time frame: 30 months

  4. number of days of platelets recovery

    Time frame: 30 months

  5. Number of death

    Time frame: 30 months

  6. number of days between remission and relapse

    Time frame: 30 months

  7. number of days between remission and death

    Time frame: 30 months

  8. number of days between remission and last follow-up date

    Time frame: 30 months

  9. number of days between Day 1 and last follow-up date

    Time frame: 30 months

  10. number of days between Day 1 and death

    Time frame: 30 months

  11. number of days between Day 1 and relapse

    Time frame: 30 months

  12. number of relapse

    Time frame: 30 months

  13. Number of cytokine

    Time frame: 25 months

  14. Number of tocilizumab

    Time frame: 25 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML) With Poor Prognosis: TOCILAM"

Acronym: Tocilam

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2020
Registry last updated
Apr 28, 2023

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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