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Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven (VENETACIBLE)

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ClinicalTrials.gov Identifier: NCT06030089
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : March 20, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:
The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Pharmacokinetic sampling Other: Vital status determination Other: Toxicity assessments Drug: Venetoclax and azacitidine combination Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE
Actual Study Start Date : February 26, 2024
Estimated Primary Completion Date : October 15, 2024
Estimated Study Completion Date : October 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Newly diagnosed AML patients
 Other: Pharmacokinetic sampling
4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2

Other: Vital status determination
Survival situation 12 months after start of treament

Other: Toxicity assessments
Toxicity events

Drug: Venetoclax and azacitidine combination
Response to treatment


Outcome Measures
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Primary Outcome Measures :
  1. Plasmatic dosage [ Time Frame: Before treatment ]
    Correlation of VEN plasma levels with inhibition of its Bcl-2 target

  2. Plasmatic dosage [ Time Frame: At Day 5 of 1st round of chemotherapies ]
    Correlation of VEN plasma levels with inhibition of its Bcl-2 target

  3. Plasmatic dosage [ Time Frame: At Day 9 of 1st round of chemotherapies ]
    Correlation of VEN plasma levels with inhibition of its Bcl-2 target

  4. Plasmatic dosage [ Time Frame: At 12 months after start of treatment or at relapse whichever comes first ]
    Correlation of VEN plasma levels with inhibition of its Bcl-2 target


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    Evaluate the overall survival


Eligibility Criteria
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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 :

  • Patient with acute myeloid leukemia (AML) not eligible for intensive chemotherapy
  • Patients aged 18 or over
  • Patient treated with the combination azacitidine (AZA) + venetoclax (VEN)
  • Patient having signed the study informed consent form
  • Patient with social security coverage

Exclusion criteria :

  • Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4
  • Presence of an active, uncontrolled infection
  • Patient participating or having participated in a clinical drug trial in the month prior to inclusion.
  • Vulnerable persons
Contacts and Locations
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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): NCT06030089


Contacts
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Contact: Thomas Cluzeau, Pr 0492035841 cluzeau.t@chu-nice.fr
Contact: Valérie FOUSSAT 0492034011

Locations
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France
Hopital la Conception Recruiting
Marseille, France
Contact: Geoffroy Venton, MD         
Sub-Investigator: Geoffroy Venton, MD         
CHU de Nice Recruiting
Nice, France
Contact: Thomas Cluzeau         
Principal Investigator: Thomas Cluzeau, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Thomas Cluzeau CHU of Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT06030089    
Other Study ID Numbers: 23-AOIP-01
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
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 Centre Hospitalier Universitaire de Nice:
acute myeloid leukemia
venetoclax
azacitidine
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Azacitidine
 Venetoclax
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors