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Expanded Access to Navitoclax

Primary Purpose

Myelofibrosis, Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Navitoclax
Venetoclax
Sponsored by
AbbVie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Myelofibrosis focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 10, 2018
    Last Updated
    January 5, 2023
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03592576
    Brief Title
    Expanded Access to Navitoclax
    Official Title
    Expanded Access to Navitoclax
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    5. Study Description

    Brief Summary
    This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to navitoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myelofibrosis, Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma
    Keywords
    Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Navitoclax
    Other Intervention Name(s)
    ABT-263
    Intervention Description
    Tablet, Oral
    Intervention Type
    Drug
    Intervention Name(s)
    Venetoclax
    Other Intervention Name(s)
    Venclexta, ABT-199, GDC-0199
    Intervention Description
    Tablet, Oral

    10. Eligibility

    Minimum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ABBVIE CALL CENTER
    Phone
    847.283.8955
    Email
    abbvieclinicaltrials@abbvie.com

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access to Navitoclax

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