Back to resultsExpanded Access to Venetoclax
Primary Purpose
Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma, Acute Myeloid Leukemia (AML)
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Venetoclax
Sponsored by
About this trial
This is an expanded access trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Eligibility Criteria
Inclusion Criteria:
- The participant must not be eligible for a venetoclax clinical trial.
- Pediatric participants may be evaluated on a case by case basis.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03123029
Brief Title
Expanded Access to Venetoclax
Official Title
Expanded Access to Venetoclax
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2023
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 Venetoclax 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
Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma, Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia (ALL), Amyloidosis, Plasma Cell Leukemia
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)
Venetoclax
Other Intervention Name(s)
ABT-199, GDC-0199
Intervention Description
Venetoclax will be administered orally.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant must not be eligible for a venetoclax clinical trial.
Pediatric participants may be evaluated on a case by case basis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Expanded Access to Venetoclax
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