A Study of ABT-263 in Combination With Dose-Intensive Rituximab, or Dose-Intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)
Part of paid clinical trials in Alhambra, California.
- Sponsor
- Genentech, Inc.
- Study ID
- NCT01087151
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ABT-263 — DRUGOral repeating dose
- rituximab — DRUGIntravenous repeating dose
Study Details
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.
Key Dates
- Start date
- Aug 31, 2010
- Status verified
- Nov 2016
- Primary completion
- Jun 30, 2012
- Completion
- Jun 30, 2012
Study Design
- Enrollment
- 118 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: A
- Experimental: B
- Experimental: C
Primary Outcome Measure
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]) ]
Locations (48)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Alhambra | California | 91801 | - |
| - | Antioch | California | 94531 | - |
| - | Berkeley | California | 94704 | - |
| - | Burbank | California | 91505 | - |
| - | Duarte | California | 91010 | - |
| - | Dublin | California | 94568 | - |
| - | La Jolla | California | 92093 | - |
| - | Los Angeles | California | 90024 | - |
| - | Los Angeles | California | 90073 | - |
| - | Los Angeles | California | 90095-1772 | - |
| - | Los Angeles | California | 90095 | - |
| - | Northridge | California | 91325 | - |
| - | Pleasant Hill | California | 94523 | - |
| - | San Leandro | California | 94578-2626 | - |
| - | San Luis Obispo | California | 93454 | - |
| - | Santa Monica | California | 90404 | - |
| - | Fort Collins | Colorado | 80528 | - |
| - | Norwalk | Connecticut | 06856 | - |
| - | Bay Pines | Florida | 33744 | - |
| - | Atlanta | Georgia | 30322 | - |
| - | Chicago | Illinois | 60612 | - |
| - | Decatur | Illinois | 62526 | - |
| - | Harvey | Illinois | 60426 | - |
| - | Tinley Park | Illinois | 60477 | - |
| - | Shreverport | Louisiana | 71103 | - |
| - | Baltimore | Maryland | 21215 | - |
| - | Bethesda | Maryland | 20817 | - |
| - | Bethesda | Maryland | 20874 | - |
| - | Randallstown | Maryland | 21133 | - |
| - | Lansing | Michigan | 48909 | - |
| - | Lansing | Michigan | 48912 | - |
| - | Omaha | Nebraska | 68114 | - |
| - | Henderson | Nevada | 89052 | - |
| - | Las Vegas | Nevada | 89148 | - |
| - | Las Vegas | Nevada | 89169 | - |
| - | Reno | Nevada | 89502 | - |
| - | Cherry Hill | New Jersey | 08003 | - |
| - | Farmington | New Mexico | 87401 | - |
| - | Oneida | New York | 13421 | - |
| - | Oswego | New York | 13126 | - |
| - | Syracuse | New York | 13210 | - |
| - | Middletown | Ohio | 45042 | - |
| - | Philadelphia | Pennsylvania | 19111 | - |
| - | Pittsburgh | Pennsylvania | 15224 | - |
| - | Corpus Christi | Texas | 78405 | - |
| - | Lubbock | Texas | 79410 | - |
| - | Lubbock | Texas | 79415 | - |
| - | Everett | Washington | 98201 | - |
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