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

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04547062

Collaborator

(none)

Enrollment

Location

29.5

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)	Drug: Tocilizumab	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Continual Reassessment Method for MTDContinual Reassessment Method for MTD

Masking:

None (Open Label)

Primary Purpose:

Treatment

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"

Actual Study Start Date :

Dec 29, 2020

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Outcome Measures

Primary Outcome Measures

number of DLT [45 days]

Secondary Outcome Measures

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]
number of days between remission and relapse [30 months]
number of days between remission and death [30 months]
number of days between remission and last follow-up date [30 months]
number of days between Day 1 and last follow-up date [30 months]
number of days between Day 1 and death [30 months]
number of days between Day 1 and relapse [30 months]
number of relapse [30 months]
Number of cytokine [25 months]
Number of tocilizumab [25 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU of Nantes	Nantes		France	44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT04547062

Other Study ID Numbers:

RC20_0282
2020-003209-77

First Posted:

Sep 14, 2020

Last Update Posted:

Jan 12, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nantes University Hospital

AML il-6 tocilizumab

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Jan 12, 2021