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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-199 | Experimental | ABT-199 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-199 | Drug | ABT-199 continuous once daily dosing |
|
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Arthritis Center /ID# 101359 | Tucson | Arizona | 85719-1478 | United States | ||
| Dartmouth-Hitchcock Med Ctr /ID# 92596 |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| Hackensack Univ Med Ctr /ID# 101417 | Hackensack | New Jersey | 07601 | United States |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |