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

Acute Myeloid Leukemia (AML) Clinical Trial

— Tocilam  

Official 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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547062
• Other study ID #: RC20_0282
• Secondary ID: 2020-003209-77
• Status: Completed
• Phase: Phase 1
• Start date: December 29, 2020
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Tocilizumab
Administration of tocilizumab at day 8 of induction following a classical induction

Locations

Country	Name	City	State
France	CHU of Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of DLT		45 days
Secondary	Number of response		25 months
Secondary	Percentage of medullary blaste		24 months
Secondary	number of days of neutrophil recovery		30 months
Secondary	number of days of platelets recovery		30 months
Secondary	Number of death		30 months
Secondary	number of days between remission and relapse		30 months
Secondary	number of days between remission and death		30 months
Secondary	number of days between remission and last follow-up date		30 months
Secondary	number of days between Day 1 and last follow-up date		30 months
Secondary	number of days between Day 1 and death		30 months
Secondary	number of days between Day 1 and relapse		30 months
Secondary	number of relapse		30 months
Secondary	Number of cytokine		25 months
Secondary	Number of tocilizumab		25 months