This Phase II, randomized, open-label, international, multicenter trial is designed to evaluate the safety and efficacy of rituximab monotherapy when given according to a dose intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when combined with dose-intense rituximab in previously untreated patients with B-cell CLL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Progression-free survival
Time frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from First Patient In [FPI])
Overall response rate (ORR)
Time frame: Approximately 40 months from FPI
Duration of response
Time frame: Approximately 40 months from FPI
Complete response (CR) rate
Time frame: Approximately 40 months from FPI
Progression-free survival as assessed by a blinded, independent review
Time frame: From randomization to the first occurrence of progression, relapse, or death on study (approximately 40 months from FPI)
ORR as assessed by a blinded, independent review
Time frame: Approximately 40 months from FPI
Duration of response as assessed by a blinded, independent review
Time frame: Approximately 40 months from FPI
CR rate as assessed by a blinded, independent review
Time frame: Approximately 40 months from FPI
Overall survival (OS)
Time frame: From randomization until death due to any cause (approximately 4 years after Last Patient In)
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Alhambra, California, United States
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Antioch, California, United States
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Berkeley, California, United States
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Burbank, California, United States
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Duarte, California, United States
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Dublin, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
...and 93 more locations