Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Cancer, Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-Hodgkin's Lymphoma
Conditions
Keywords
Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), Non-Hodgkin's Lymphoma (NHL), Acute Lymphoblastic Leukemia (ALL), Cancer, Venetoclax
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.
Interventions
DRUGVenetoclax
oral; film-coated tablets or tablets for oral suspension
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
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, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed