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

Primary Purpose

Acute Myeloid Leukemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharmacokinetic sampling
Vital status determination
Toxicity assessments
Venetoclax and azacitidine combination
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia, venetoclax, azacitidine

Eligibility Criteria

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

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

Sites / Locations

  • Hopital la Conception
  • CHU de Nice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax

Arm Description

Newly diagnosed AML patients

Outcomes

Primary Outcome Measures

Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage
Correlation of VEN plasma levels with inhibition of its Bcl-2 target

Secondary Outcome Measures

Overall survival
Evaluate the overall survival

Full Information

First Posted
August 18, 2023
Last Updated
September 6, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT06030089
Brief Title
Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven
Acronym
VENETACIBLE
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
October 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myeloid leukemia, venetoclax, azacitidine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Arm Type
Experimental
Arm Description
Newly diagnosed AML patients
Intervention Type
Other
Intervention Name(s)
Pharmacokinetic sampling
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Vital status determination
Intervention Description
Survival situation 12 months after start of treament
Intervention Type
Other
Intervention Name(s)
Toxicity assessments
Intervention Description
Toxicity events
Intervention Type
Drug
Intervention Name(s)
Venetoclax and azacitidine combination
Intervention Description
Response to treatment
Primary Outcome Measure Information:
Title
Plasmatic dosage
Description
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time Frame
Before treatment
Title
Plasmatic dosage
Description
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time Frame
At Day 5 of 1st round of chemotherapies
Title
Plasmatic dosage
Description
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time Frame
At Day 9 of 1st round of chemotherapies
Title
Plasmatic dosage
Description
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Time Frame
At 12 months after start of treatment or at relapse whichever comes first
Secondary Outcome Measure Information:
Title
Overall survival
Description
Evaluate the overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Cluzeau, Pr
Phone
0492035841
Email
cluzeau.t@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie FOUSSAT
Phone
0492034011
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Cluzeau
Organizational Affiliation
CHU of Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital la Conception
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffroy Venton, MD
First Name & Middle Initial & Last Name & Degree
Geoffroy Venton, MD
Facility Name
CHU de Nice
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Cluzeau
First Name & Middle Initial & Last Name & Degree
Thomas Cluzeau, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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