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Expanded Access to Navitoclax

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: NCT03592576
Expanded Access Status : Available
First Posted : July 19, 2018
Last Update Posted : January 6, 2023
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 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.

Condition or disease Intervention/treatment
Myelofibrosis Acute Lymphocytic Leukemia (ALL) Lymphoblastic Lymphoma Drug: Navitoclax 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 Navitoclax

Resource links provided by the National Library of Medicine

Drug Information available for: Venetoclax

Interventions
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Intervention Details:
  • Drug: Navitoclax
    Tablet, Oral
    Other Name: ABT-263
  • Drug: Venetoclax
    Tablet, Oral
    Other Names:
    • Venclexta
    • ABT-199
    • GDC-0199
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers:   No
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): NCT03592576


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03592576    
Other Study ID Numbers: C19-199
C19-922 ( Other Identifier: AbbVie )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: July 2022
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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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Venetoclax
Navitoclax
Antineoplastic Agents