Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma
NCT ID: NCT00060671
Last Updated: 2015-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
800 participants
INTERVENTIONAL
2005-01-31
2006-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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rituximab
Pixantrone (BBR 2778)
Eligibility Criteria
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Inclusion Criteria
* Presenting with an episode of progressive disease, following 1-5 prior treatments (with either radiation, chemotherapy or rituximab).
Exclusion Criteria
* Patients known to have an allergic reaction to rituximab or murine derived proteins.
18 Years
ALL
No
Sponsors
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CTI BioPharma
INDUSTRY
Responsible Party
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Locations
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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
Orange Park Cancer Center
Orange Park, Florida, United States
University of Chicago Medical Center Hematology / Oncology
Chicago, Illinois, United States
Illinois Masonic Cancer Center
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
Saint 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
East Orange VA Medical Center
East Orange, New Jersey, United States
Hematology Oncology Associates of NJ
Paramus, New Jersey, 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
Glens Falls Cancer Center
Glens Falls, New York, United States
North Shore - Long Island Jewish Health System
New Hyde Park, New York, United States
New York University
New York, New York, United States
Upstate NY Cancer Research
Rochester, New York, United States
South Shore Hematology-Oncology Associates
Rockville Centre, 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
The West Clinic
Memphis, Tennessee, United States
Central Utah Medical Clinic Hematology-Oncology
Provo, Utah, United States
Oncology of Wisconsin
Glendale, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Rhinelander Regional Medical Group Onc.
Rhinelander, Wisconsin, United States
Countries
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References
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Santoro A; Voglova J; Gabrail N; Ciuleanu T; Liberati M; Hancock BW; Stromatt S; Caballero D; Comparative Trial of Pixantrone + Rituximab vs Single agent Rituximab in the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma; American Society of Clinical Oncology abstract and poster; Part 1, Vol 24 No 18S, June 20 supplement, 2006: 7578
Other Identifiers
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AZA III 02
Identifier Type: -
Identifier Source: org_study_id
NCT00062361
Identifier Type: -
Identifier Source: nct_alias
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