Expanded Access to Navitoclax

NCT03592576 | Unknown

• 2 other identifiers: C19-199C19-922
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myelofibrosis; Acute Lymphocytic Leukemia (ALL); Lymphoblastic Lymphoma

Keywords

Expanded Access; Pre-approval Access; Compassionate Use; Special Access Program; Named Patient Basis; Special Access Scheme

Interventions

Navitoclax DRUG

Tablet, Oral

Also known as: ABT-263

Venetoclax DRUG

Tablet, Oral

Also known as: Venclexta, ABT-199, GDC-0199

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Primary Myelofibrosis; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

navitoclax; venetoclax

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 19, 2018
• Last Updated: May 6, 2024

Record last verified: 2024-05