A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/8/2019 |
Start Date: | January 13, 2014 |
End Date: | March 30, 2019 |
A Phase IB, Open-Label Study Evaluating the Safety and Pharmacokinetics of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine+Rituximab (BR) or Bendamustine+Obinutuzumab (BG) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia
This multi-center, open-label, dose-finding study will evaluate the safety and
pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with
bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to
participants with relapsed/refractory or previously untreated CLL. The study will explore two
schedules for drug administration, Schedule A (venetoclax introduced before other agents) and
Schedule B (introduced after other agents). In addition, the study will explore two
venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional).
The study is comprised of two stages for each participant population: a dose-finding stage
and a safety-expansion stage. The dose-finding stage will explore multiple doses of
venetoclax to be used in combination with fixed doses of BR or BG.
pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with
bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to
participants with relapsed/refractory or previously untreated CLL. The study will explore two
schedules for drug administration, Schedule A (venetoclax introduced before other agents) and
Schedule B (introduced after other agents). In addition, the study will explore two
venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional).
The study is comprised of two stages for each participant population: a dose-finding stage
and a safety-expansion stage. The dose-finding stage will explore multiple doses of
venetoclax to be used in combination with fixed doses of BR or BG.
Inclusion Criteria:
- Diagnosis of relapsing/refractory or previously untreated CLL
- Eastern Cooperative Oncology Group (ECOG) performance score of less than equal to
(=) 1
- Adequate bone marrow function
- Adequate coagulation, renal and hepatic function
- Hematological values within the limits independent of growth factor support or
transfusion unless cytopenia is caused by the underlying disease, i.e., no evidence of
additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone
marrow)
Exclusion Criteria:
- Participants received an allogeneic stem cell transplant
- Known human immunodeficiency virus (HIV) positivity
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Positive test results for chronic hepatitis B infection and hepatitis C virus (HCV)
- Received any anti-cancer therapy including chemotherapy or radiotherapy, steroid
therapy for anti-neoplastic intent, and investigational therapy, including targeted
small molecule agents within 28 days prior to the first dose of study drug or has not
recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of
the previous therapy
- Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic,
immunologic, cardiovascular, or hepatic disease
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