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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
Not Enrolling
Both
Lymphocytic Leukemia, Chronic

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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