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
2 other identifiers
interventional
12
1 country
1
Brief Summary
This is a phase 1 dose escalation study testing the addition of an anti-IL6 (tocilizumab) to standard induction chemotherapy for high-risk AML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedStudy Start
First participant enrolled
December 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2023
CompletedApril 28, 2023
April 1, 2023
2.3 years
September 4, 2020
April 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of DLT
45 days
Secondary Outcomes (14)
Number of response
25 months
Percentage of medullary blaste
24 months
number of days of neutrophil recovery
30 months
number of days of platelets recovery
30 months
Number of death
30 months
- +9 more secondary outcomes
Interventions
Administration of tocilizumab at day 8 of induction following a classical induction
Eligibility Criteria
You may qualify if:
- \- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU of Nantes
Nantes, 44093, France
Related Publications (1)
Peterlin P, Garnier A, Le Bourgeois A, Guillaume T, Le Bris Y, Theisen O, Bene MC, Eveillard M, Rimbert M, Jullien M, Planche L, Gaschet J, Chevallier P. Tocilizumab in combination with a standard induction chemotherapy in acute myeloid leukaemia patients (TOCILAM study): a single-centre, single-arm, phase 1 trial. EClinicalMedicine. 2023 Sep 28;64:102254. doi: 10.1016/j.eclinm.2023.102254. eCollection 2023 Oct.
PMID: 37786451DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2020
First Posted
September 14, 2020
Study Start
December 29, 2020
Primary Completion
April 4, 2023
Study Completion
April 4, 2023
Last Updated
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share