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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)

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ClinicalTrials.gov Identifier: NCT04547062
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Continual 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 : December 29, 2020
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : June 15, 2023



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


Primary Outcome Measures :
  1. number of DLT [ Time Frame: 45 days ]

Secondary Outcome Measures :
  1. Number of response [ Time Frame: 25 months ]
  2. Percentage of medullary blaste [ Time Frame: 24 months ]
  3. number of days of neutrophil recovery [ Time Frame: 30 months ]
  4. number of days of platelets recovery [ Time Frame: 30 months ]
  5. Number of death [ Time Frame: 30 months ]
  6. number of days between remission and relapse [ Time Frame: 30 months ]
  7. number of days between remission and death [ Time Frame: 30 months ]
  8. number of days between remission and last follow-up date [ Time Frame: 30 months ]
  9. number of days between Day 1 and last follow-up date [ Time Frame: 30 months ]
  10. number of days between Day 1 and death [ Time Frame: 30 months ]
  11. number of days between Day 1 and relapse [ Time Frame: 30 months ]
  12. number of relapse [ Time Frame: 30 months ]
  13. Number of cytokine [ Time Frame: 25 months ]
  14. Number of tocilizumab [ Time Frame: 25 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547062


Locations
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France
CHU of Nantes Recruiting
Nantes, France, 44093
Contact: Peterlin Pierre    02 40 08 74 18    pierre.peterlin@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04547062    
Other Study ID Numbers: RC20_0282
2020-003209-77 ( EudraCT Number )
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
AML il-6 tocilizumab
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid