A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Bendamustine/Rituximab (BR) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lymphocytic Leukemia, Chronic
Both
Lymphocytic Leukemia, Chronic
Trial Information
A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Bendamustine/Rituximab (BR) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia
Inclusion Criteria:
- Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic
leukemia
- Eastern Cooperative Oncology Group (ECOG) performance score of >/=1
- Adequate bone marrow function
- Adequate renal and hepatic function
Exclusion Criteria:
- Patient received an allogeneic stem cell transplant
- Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Investigational or anti-cancer therapy within 14 days of study start (30 days for
biologic agents for anti-neoplastic intent)
- History of significant renal, neurologic, psychiatric, endocrinologic, metabolic,
immunologic, cardiovascular, or hepatic disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Outcome Time Frame:
approximately 30 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
GO28440
NCT ID:
NCT01671904
Start Date:
May 2013
Completion Date:
September 2015
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Seattle, Washington 98195 | |
| Washington, District of Columbia |
