Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma, Mixed-Cell, FollicularLymphoma, Low-GradeLymphoma, FollicularLymphoma, Small Cleaved-Cell, Follicular
- Registration Number
- NCT00060671
- Lead Sponsor
- CTI BioPharma
- Brief Summary
The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients' remission, compared to rituximab alone.
- Detailed Description
This trial is being conducted in patients with indolent (or low-grade) non-Hodgkin's lymphoma, who have either relapsed or been refractory to previous treatment.
Pixantrone belongs to the DNA intercalator family of chemotherapy agents, which includes anthracyclines. DNA intercalators are commonly used to treat patients with indolent NHL, often in combination with the monoclonal antibody rituximab. This study represents the first large-scale, comparative trial in indolent NHL, designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator, is significantly higher than seen in patients treated with rituximab alone.
This trial is randomized and controlled, which means that participating patients will be randomly assigned to one of two treatment groups:
1. Patients treated with both pixantrone and rituximab, in combination
2. Patients treated with only rituximab
This trial is expected to recruit around 800 patients in the US, Europe and Israel, with 400 patients recruited to each group.
Patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone For 5 years post treatment
- Secondary Outcome Measures
Name Time Method To compare BBR 2778 + rituximab versus rituximab for: For 5 years post treatment * objective overall response rate (ORR; CR + PR)
* objective complete response rate (CRR)
* rate of molecular remission
* time to response
* time to complete response
* duration of response
* Time to Tumor Progression requiring treatment
* Quality-Adjusted Time To Progression (QATTP)
* overall survival
* disease-specific survival
* safety/tolerability
Trial Locations
- Locations (38)
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Kenmar Research Institute
🇺🇸Los Angeles, California, United States
Rocky Moutain Cancer Center
🇺🇸Denver, Colorado, United States
Pasco, Hernando Oncology Associates, P.A.
🇺🇸New Port Richey, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Illinois Masonic Cancer Center
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center Hematology / Oncology
🇺🇸Chicago, Illinois, United States
Edward Cancer Center
🇺🇸Naperville, Illinois, United States
Hope Center
🇺🇸Terre Haute, Indiana, United States
Commonwealth Hematology/Oncology
🇺🇸Danville, Kentucky, United States
New England Hematology / Oncology Associates
🇺🇸Wellesley, Massachusetts, United States
St. Joseph Oncology
🇺🇸St Joseph, Missouri, United States
Christian Hospital
🇺🇸St Louis, Missouri, United States
St. Johns Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Hematology - Oncology Centers of N. Rockies
🇺🇸Billings, Montana, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Hematology Oncology Associates of NJ
🇺🇸Paramus, New Jersey, United States
East Orange VA Medical Center
🇺🇸East Orange, New Jersey, United States
Oncology of Wisconsin
🇺🇸Glendale, Wisconsin, United States
Summit Medical Group/Overlook Onc Center
🇺🇸Summit, New Jersey, United States
New Mexico Oncology / Hematology
🇺🇸Albuquerque, New Mexico, United States
HemOnCare, P.C.
🇺🇸Brooklyn, New York, United States
New York University
🇺🇸New York, New York, United States
Upstate NY Cancer Research
🇺🇸Rochester, New York, United States
Clinworks, Inc
🇺🇸Charlotte, North Carolina, United States
Private Practice
🇺🇸Canton, Ohio, United States
Blair Medical Associates
🇺🇸Altoona, Pennsylvania, United States
Lancaster Cancer Center, LTD
🇺🇸Lancaster, Pennsylvania, United States
Santee Hematology Oncology
🇺🇸Sumter, South Carolina, United States
Glens Falls Cancer Center
🇺🇸Glens Falls, New York, United States
North Shore - Long Island Jewish Health System
🇺🇸New Hyde Park, New York, United States
South Shore Hematology-Oncology Associates
🇺🇸Rockville Centre, New York, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Central Utah Medical Clinic Hematology-Oncology
🇺🇸Provo, Utah, United States
Orange Park Cancer Center
🇺🇸Orange Park, Florida, United States
Rhinelander Regional Medical Group Onc.
🇺🇸Rhinelander, Wisconsin, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States