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Expanded Access to Venetoclax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123029
Expanded Access Status : Available
First Posted : April 21, 2017
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia (CLL) Multiple Myeloma Acute Myeloid Leukemia (AML) Non-Hodgkin's Lymphoma Acute Lymphoblastic Leukemia (ALL) Amyloidosis Plasma Cell Leukemia Drug: Venetoclax

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Venetoclax

Resource links provided by the National Library of Medicine

Drug Information available for: Venetoclax

Interventions
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Intervention Details:
  • Drug: Venetoclax
    Venetoclax will be administered orally.
    Other Names:
    • ABT-199
    • GDC-0199
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123029


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03123029    
Other Study ID Numbers: C16-431
C19-920 ( Other Grant/Funding Number: Abbvie )
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024
Keywords provided by AbbVie:
Expanded Access
Pre-approval Access
Compassionate Use
 Special Access Program
Named Patient Basis
Special Access Scheme
Additional relevant MeSH terms:
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Leukemia
Multiple Myeloma
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Plasma Cell
Amyloidosis
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Lymphatic Diseases
Leukemia, Lymphoid
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Venetoclax