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Expanded Access to Venetoclax

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ClinicalTrials.gov Identifier: NCT03123029
Expanded Access Status : Available
First Posted : April 21, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date April 18, 2017
First Posted Date April 21, 2017
Last Update Posted Date July 15, 2019
 
Descriptive Information
Brief Title Expanded Access to Venetoclax
Official Title Expanded Access to Venetoclax
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. Participating sites will be added as they apply for and are approved for the EAP. 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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition
  • Chronic Lymphocytic Leukemia (CLL)
  • Multiple Myeloma
  • Acute Myeloid Leukemia (AML)
  • Non-Hodgkin's Lymphoma
  • Acute Lymphoblastic Leukemia (ALL)
  • Amyloidosis
Intervention Drug: Venetoclax
Venetoclax will be administered orally.
Other Names:
  • ABT-199
  • GDC-0199
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03123029
Other Study ID Numbers C16-431
C19-920 ( Other Identifier: AbbVie )
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date July 2019