Back to resultsExpanded 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
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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