An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study.

Official Title
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An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: ABT-199


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject. Exclusion Criteria: Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other). Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy. Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

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: ABT-199<br>ABT-199 monotherapy | Drug: ABT-199<br>* ABT-199 continuous once daily dosing<br>* Other names: GDC-0199;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac assessment findings | Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram | Measured from Day 1 up to 6 years after the last subject has enrolled in the study | 
| Percentage of subjects with adverse events | Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study | Measured up to 6 years after the last subject has enrolled in the study | 
| Change in clinical laboratory test results | Chemistry, coagulation, hematology, lymphocyte enumeration, paraproteins, urinalysis, and, if appropriate, viral polymerase chain reaction and viral serologies | Measured from Day 1 up to 6 years after the last subject has enrolled in the study | 
| Number of subjects with adverse events | Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study | Measured up to 6 years after the last subject has enrolled in the study | 
| Change in physical exam finding, including vital signs | Body temperature, weight, blood pressure, heart rate | Measured from Day 1 up to 6 years after the last subject has enrolled in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABT-199, Cancer, GDC-0199, non-Hodgkin's lymphoma, Relapsed, Refractory, Safety