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Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE (VEN-R DASA)

Primary Purpose

Acute Myeloid Leukemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

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

Inclusion Criteria: Confirmed diagnosis of AML except acute promyelocytic leukemia (AML M3) Age ≥ 18 years ECOG ≤3 VEN-AZA refractory defined as no response or as a progression after one or two cycles of VEN-AZA whatever the dose and the treatment duration Signed informed consent form Affiliation to a social security system, or beneficiary of such a system Exclusion Criteria: Central nervous system involvement Heart failure Liver failure Kidney failure Contraindication to DASATINIB Positive for HIV, Hepatitis B or C Pregnant or breastfeeding woman No efficient contraception for the women of childbearing age Emergency situation person or not able to express his/her informed consent Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice) Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons

Sites / Locations

    Outcomes

    Primary Outcome Measures

    tumor response
    Objective response rate after 2 cycles of 28 days DASATINIB defined as the rate of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) according to ELN 2022 criteria.

    Secondary Outcome Measures

    response rates
    Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.
    Time to response
    Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)
    Duration of relapse-free period
    Duration of relapse-free period (time between the response time and the relapse)
    Event-free survival
    Event-free survival (EFS, time between start of treatment and relapse, progression or death)
    Overall survival
    Overall survival (duration of survival from the start of the treatment)
    Occurrence of Adverse Events
    Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction

    Full Information

    First Posted
    September 20, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Institut Paoli-Calmettes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06055621
    Brief Title
    Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
    Acronym
    VEN-R DASA
    Official Title
    Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2025 (Anticipated)
    Study Completion Date
    October 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Paoli-Calmettes

    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
    The goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy. Participants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myeloid Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Dasatinib
    Intervention Description
    Daily orally administration of DASATINIB
    Primary Outcome Measure Information:
    Title
    tumor response
    Description
    Objective response rate after 2 cycles of 28 days DASATINIB defined as the rate of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) according to ELN 2022 criteria.
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    response rates
    Description
    Different response rates (RC, CRi, or partial remission (PR)) according to ELN 2022 criteria.
    Time Frame
    3 months
    Title
    Time to response
    Description
    Time to response (time between the start of the treatment until achievement of the CR, CRi or PR)
    Time Frame
    3 months
    Title
    Duration of relapse-free period
    Description
    Duration of relapse-free period (time between the response time and the relapse)
    Time Frame
    3 months
    Title
    Event-free survival
    Description
    Event-free survival (EFS, time between start of treatment and relapse, progression or death)
    Time Frame
    3 months
    Title
    Overall survival
    Description
    Overall survival (duration of survival from the start of the treatment)
    Time Frame
    3 months
    Title
    Occurrence of Adverse Events
    Description
    Occurrence of Adverse Events according to CTCAE v5.0 and Serious Adverse Reaction
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of AML except acute promyelocytic leukemia (AML M3) Age ≥ 18 years ECOG ≤3 VEN-AZA refractory defined as no response or as a progression after one or two cycles of VEN-AZA whatever the dose and the treatment duration Signed informed consent form Affiliation to a social security system, or beneficiary of such a system Exclusion Criteria: Central nervous system involvement Heart failure Liver failure Kidney failure Contraindication to DASATINIB Positive for HIV, Hepatitis B or C Pregnant or breastfeeding woman No efficient contraception for the women of childbearing age Emergency situation person or not able to express his/her informed consent Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice) Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique GENRE, Dr
    Phone
    +33491223778
    Email
    drci.up@ipc.unicancer.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

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