A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Chronic Lymphocytic Leukemia
Trial Information
A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
This is a Phase 3, multicenter, 2-arm, randomized, controlled, parallel-group, open label
clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta
(PI3K-delta) inhibitor GS-1101 (CAL-101) in combination with ofatumumab for previously
treated chronic lymphocytic leukemia.
Inclusion Criteria:
- Adult subjects with previously treated recurrent CLL who have measurable
lymphadenopathy
- Require therapy for CLL
- Have experienced CLL progression <24 months since the completion of the last prior
therapy
- Have disease that is not refractory to ofatumumab
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free survival
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Ronald Dubowy, MD
Investigator Role:
Study Director
Investigator Affiliation:
Gilead Sciences
Authority:
United States: Food and Drug Administration
Study ID:
GS-US-312-0119
NCT ID:
NCT01659021
Start Date:
November 2012
Completion Date:
December 2017
Related Keywords:
- Chronic Lymphocytic Leukemia
- CLL
- Chronic Lymphocytic Leukemia
- CAL-101
- Ofatumumab
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Washington University Medical Center | Saint Louis, Missouri 63105 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| University of California San Diego | La Jolla, California 92093 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| South Carolina Oncology Associates | Columbia, South Carolina 29201 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| The Center for Cancer and Hematologic Disease | Cherry Hill, New Jersey 08003 |
| Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| Oncology Hematology Care, Inc. | Cincinnati, Ohio 45219 |
| Kaiser Permanente | Sacramento, California |
| Oregon Health and Science University | Portland, Oregon 97201 |
| Utah Cancer Specialists | Salt Lake City, Utah 84106 |
| Northwest Medical Specialties | Tacoma, Washington 98405 |
| The Ohio State University Medical Center | Columbus, Ohio 43210 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| Montgomery Cancer Center | Mt. Sterling, Kentucky 40353 |
| Center for Cancer and Blood Disorders, PC | Bethesda, Maryland 20817 |
| Kaiser Permanente of Colorado | Aurora, Colorado 80014 |
| Georgia Health Sciences University | Augusta, Georgia 30912 |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia, Pennsylvania 19104 |
| Providence Everett Regional Medical Center, Cancer Research Dept. | Everett, Washington 98201 |
| Cancer Specialists of North Florida | Jacksonville, Florida 32256 |
| California Cancer Associates for Research and Excellence (CCARE) | Fresno, California 93720 |
