A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant
Eligible patients will be randomized to treatment with pixantrone plus rituximab or
gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience
progressive disease during study treatment, early follow- up, or intermediate follow-up,
they enter the survival follow up period. Patients who complete study treatment or
discontinue study treatment for any other reason will participate in the follow-up periods.
Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week
follow-up period.
Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will
enter an additional 72-week follow-up period.
Survival Follow-Up: All patients will be monitored for survival.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Overall Survival Analysis
OS is defined as the time from randomization until death due to any cause.
Randomization through death
No
United States: Food and Drug Administration
PIX306 (PIX-R Trial)
NCT01321541
April 2011
June 2017
Name | Location |
---|---|
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Carle Cancer Center | Urbana, Illinois 61801 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Crossroads Cancer Center | Effingham, Illinois 62401 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Highlands Oncology Group | Springdale, Arkansas 72764 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Blood and Marrow Transplant Group of Georgia | Atlanta, Georgia 30342-1601 |
Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Dayton Clinical Oncology Program | Dayton, Ohio 45420 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
Northwest Cancer Specialists, PC | Vancouver, Washington 98684 |
Hematology-Oncology Associates of Northern New Jersey | Morristown, New Jersey 07962 |
South Carolina Cancer Specialists | Hilton Head Island, South Carolina 29925 |
Cancer Care Specialists of Central Illinois | Decatur, Illinois 62256 |
Nebraska Hematology-Oncology, PC | Lincoln, Nebraska 68506 |
Baptist Hospital East | Louisville, Kentucky 40207 |
Harry and Jeanette Weinberg Cancer Institute at Franklin Square | Baltimore, Maryland 21237 |
Center for Cancer and Blood Disorders, PC | Bethesda, Maryland 20817 |
Northwest Cancer Specialists, PC | Portland, Oregon 97225 |
Cancer Care Centers of South Texas-HOAST | San Antonio, Texas 78229 |
North Shore Hematology/Oncology Associates | East Setauket, New York |
Blue Ridge Cancer Care | Roanoke, Virginia 24019 |
Metro Minnesota Community Clinical Oncology Program | St. Louis Park, Minnesota |
George Washington University Department of Medicine | Washington, District of Columbia 20037 |
Integrated Community Oncology Network-St. Vincent's | Jacksonville, Florida 32204 |
Integrated Community Oncology Network-Southside | Jacksonville, Florida 32207 |
Carle Physician Group | Danville, Illinois 61832 |
Carle Foundation Physician Services | Mattoon, Illinois 61938 |
Cancer & Hematology Center of Western Michigan | Grand Rapids, Michigan 49450 |
Metro Minnesota CCOP-Unity Hospital | Fridley, Minnesota 55432 |
Metro Minnesota CCOP-St. Johns | Maplewood, Minnesota 55109 |
Metro Minnesota CCOP-Regions Hospital | St. Paul, Minnesota 55101 |
Dayton Physicians, LLC | Dayton, Ohio 45415 |
Toledo Clinical Cancer Center | Toledo, Ohio 43617 |
Toledo Clinic Cancer Center-Toledo | Toledo, Ohio 43623 |
Mercy Cancer Center at St. Anne's | Toledo, Ohio 43623 |
Upstate Oncology Associates | Greenville, South Carolina 29615 |
Saint Vincent Hospital Green Bay Oncology | Green Bay, Wisconsin 54301 |
Green Bay Oncology-St. Mary's Hospital MC | Green Bay, Wisconsin 54303 |