An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Phase 3

Active, not recruiting

• Conditions: Chronic Lymphocytic Leukemia; Acute Myeloid Leukemia; Multiple Myeloma; Non-Hodgkin's Lymphoma; Acute Lymphoblastic Leukemia; Cancer
• Interventions: Drug: Venetoclax

• Registration Number: NCT03844048
• Lead Sponsor: AbbVie

Brief Summary

The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-18
• Study Start: 2019-09-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug.
• Male subject agrees to refrain from sperm donation.
• Female subjects must not be pregnant or breastfeeding.

Exclusion Criteria

• None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venetoclax	Venetoclax	Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).	An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Trial Locations

Locations (56)

Dartmouth-Hitchcock Medical Center /ID# 210555; 🇺🇸 Lebanon, New Hampshire, United States

University of Arizona Cancer Center - Tucson /ID# 210548; 🇺🇸 Tucson, Arizona, United States

UCLA Santa Monica Hematology Oncology /ID# 210551; 🇺🇸 Los Angeles, California, United States

Ingalls Memorial Hosp /ID# 210553; 🇺🇸 Harvey, Illinois, United States

Dana-Farber Cancer Institute /ID# 215360; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132; 🇺🇸 Ann Arbor, Michigan, United States

Swedish Cancer Institute /ID# 213120; 🇺🇸 Seattle, Washington, United States

Royal Prince Alfred Hospital /ID# 239557; 🇦🇺 Camperdown, New South Wales, Australia

St George Hospital /ID# 225589; 🇦🇺 Kogarah, New South Wales, Australia

Liverpool Hospital /ID# 225591; 🇦🇺 Liverpool, New South Wales, Australia

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