Non-Hodgkin's Lymphoma
Conditions
Keywords
ABT-199, Cancer, GDC-0199, non-Hodgkin's lymphoma, Relapsed, Refractory, Safety
Brief summary
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.
Interventions
DRUGABT-199
ABT-199 continuous once daily dosing
Sponsors
Genentech, Inc.
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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* Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac assessment findings | Measured from Day 1 up to 6 years after the last subject has enrolled in the study | Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram |
| Percentage of subjects with adverse events | Measured up to 6 years after the last subject has enrolled in the study | Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study |
| Change in clinical laboratory test results | Measured from Day 1 up to 6 years after the last subject has enrolled in the study | Chemistry, coagulation, hematology, lymphocyte enumeration, paraproteins, urinalysis, and, if appropriate, viral polymerase chain reaction and viral serologies |
| Number of subjects with adverse events | Measured up to 6 years after the last subject has enrolled in the study | Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study |
| Change in physical exam finding, including vital signs | Measured from Day 1 up to 6 years after the last subject has enrolled in the study | Body temperature, weight, blood pressure, heart rate |
Countries
United States
Outcome results
None listed