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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Venetoclax


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venetoclax<br>Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled. | Drug: Venetoclax<br>* oral; film-coated tablets or tablets for oral suspension<br>* Other names: Venclexta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | 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. | From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), Non-Hodgkin's Lymphoma (NHL), Acute Lymphoblastic Leukemia (ALL), Venetoclax