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

NCT03844048 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	AbbVie
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	165
Start date	2019-09-06
Completion	2027-08

Conditions

• Chronic Lymphocytic Leukemia
• Acute Myeloid Leukemia
• Multiple Myeloma
• Non-Hodgkin's Lymphoma
• Acute Lymphoblastic Leukemia
• Cancer

Interventions

• Venetoclax

Primary outcomes

• 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.

Countries

United States, Australia, Austria, Belgium, Canada, Denmark, France, Greece, Hong Kong, Ireland, Japan, Mexico, New Zealand, Poland, Portugal, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom