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Expanded Access to Navitoclax

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ClinicalTrials.gov Identifier: NCT03592576
Expanded Access Status : No longer available
First Posted : July 19, 2018
Last Update Posted : May 6, 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 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

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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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No Contacts or Locations Provided
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: May 6, 2024
Last Verified: May 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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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Venetoclax
Navitoclax
Antineoplastic Agents