A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients With Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents
This is a Phase 2, open-label, single-arm, 2-stage, efficacy, safety, and pharmacodynamic
study of CAL-101 in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL)
that is refractory both to rituximab and to alkylating-agent-containing chemotherapy.
Eligible patients will initiate oral therapy with CAL-101 at a starting dose of 150 mg taken
twice per day. Treatment with CAL-101 can continue in compliant patients as long as the
study is still ongoing and the patients appear to be benefiting from treatment with
acceptable safety.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate during treatment with CAL-101 based on standard criteria
every 8-12 weeks
No
Langdon Miller, MD
Study Director
Gilead Sciences
United States: Food and Drug Administration
101-09
NCT01282424
January 2011
December 2018
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Winship Cancer Institute | Atlanta, Georgia 30322 |
Charles A. Sammons Cancer Center | Dallas, Texas 75246 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Pacific Shores Medical Group | Long Beach, California 90813 |
Cancer Care Associates Medical Group | Torrance, California 90505 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
South Carolina Oncology Associates | Columbia, South Carolina 29201 |
UCLA | Los Angeles, California 90095 |
St. Jude Medical Center | Fullerton, California 92835 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
University of Virginia Medical Center | Charlottesville, Virginia 22908 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Central Coast Medical Oncology | Santa Maria, California 93454 |
Northwestern University Robert H. Lurie Comprehensive Cancer Center | Chicago, Illinois 60611-2941 |
University of Medicine and Dentistry of NJ | Newark, New Jersey 07107 |
Central Hematology Oncology Medical Group | Alhambra, California 91801 |
St. Mary's Hospital Regional Cancer Center | Grand Junction, Colorado 81502 |
The Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210 |
Collaborative Research Group, LLC | Boynton Beach, Florida 33435 |
Oncology and Hematology Specialist | Denville, New Jersey 07834 |
John Theurer Cancer Center Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Weill Cornell -New York Presbyterian Hospital | New York, New York 10002 |
St-Luke's Roosevelt Hospital | New York, New York 10019 |
Chattanooga Hem/Oncology Ass (SCRI) | Chattanooga, Tennessee 37404 |
Virginia Cancer Center | Richmond, Virginia 23230 |