An Open-label, Multicenter, Randomized Phase II Trial Comparing the Efficacy, Safety, and Pharmacokinetics of GA101 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete response/complete response with incomplete marrow recovery/partial response), assessments according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines
Week 24
No
Jamie Hirata, Pharm.D
Study Director
Genentech
United States: Food and Drug Administration
GAO4768g
NCT01414205
October 2011
July 2016
Name | Location |
---|---|
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Louisville, Kentucky 40207 | |
McLean, Virginia 22101 | |
Hackensack, New Jersey 07601 | |
Denver, Colorado | |
Eugene, Oregon | |
Indianapolis, Indiana | |
Tulsa, Oklahoma | |
Coeur D'alene, Idaho 83814 |