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

April 27, 2023 updated by: Nantes University Hospital

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"

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU of Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of DLT
Time Frame: 45 days
45 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of response
Time Frame: 25 months
25 months
Percentage of medullary blaste
Time Frame: 24 months
24 months
number of days of neutrophil recovery
Time Frame: 30 months
30 months
number of days of platelets recovery
Time Frame: 30 months
30 months
Number of death
Time Frame: 30 months
30 months
number of days between remission and relapse
Time Frame: 30 months
30 months
number of days between remission and death
Time Frame: 30 months
30 months
number of days between remission and last follow-up date
Time Frame: 30 months
30 months
number of days between Day 1 and last follow-up date
Time Frame: 30 months
30 months
number of days between Day 1 and death
Time Frame: 30 months
30 months
number of days between Day 1 and relapse
Time Frame: 30 months
30 months
number of relapse
Time Frame: 30 months
30 months
Number of cytokine
Time Frame: 25 months
25 months
Number of tocilizumab
Time Frame: 25 months
25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2020

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

September 4, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC20_0282
  • 2020-003209-77 (EudraCT Number)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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