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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)

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring AML il-6 tocilizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU of Nantes

Outcomes

Primary Outcome Measures

number of DLT

Secondary Outcome Measures

Number of response
Percentage of medullary blaste
number of days of neutrophil recovery
number of days of platelets recovery
Number of death
number of days between remission and relapse
number of days between remission and death
number of days between remission and last follow-up date
number of days between Day 1 and last follow-up date
number of days between Day 1 and death
number of days between Day 1 and relapse
number of relapse
Number of cytokine
Number of tocilizumab

Full Information

First Posted
September 4, 2020
Last Updated
April 27, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04547062
Brief 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)
Acronym
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"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
April 4, 2023 (Actual)
Study Completion Date
April 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)
Keywords
AML il-6 tocilizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Continual Reassessment Method for MTD
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Administration of tocilizumab at day 8 of induction following a classical induction
Primary Outcome Measure Information:
Title
number of DLT
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Number of response
Time Frame
25 months
Title
Percentage of medullary blaste
Time Frame
24 months
Title
number of days of neutrophil recovery
Time Frame
30 months
Title
number of days of platelets recovery
Time Frame
30 months
Title
Number of death
Time Frame
30 months
Title
number of days between remission and relapse
Time Frame
30 months
Title
number of days between remission and death
Time Frame
30 months
Title
number of days between remission and last follow-up date
Time Frame
30 months
Title
number of days between Day 1 and last follow-up date
Time Frame
30 months
Title
number of days between Day 1 and death
Time Frame
30 months
Title
number of days between Day 1 and relapse
Time Frame
30 months
Title
number of relapse
Time Frame
30 months
Title
Number of cytokine
Time Frame
25 months
Title
Number of tocilizumab
Time Frame
25 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU of Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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