Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma
An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)
1 other identifier
interventional
800
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2005
Shorter than P25 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2003
CompletedFirst Posted
Study publicly available on registry
May 12, 2003
CompletedStudy Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJanuary 19, 2015
May 1, 2013
1 year
May 9, 2003
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To compare BBR 2778 + rituximab versus rituximab for:
For 5 years post treatment
Interventions
Eligibility Criteria
You may qualify if:
- Patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL), including follicular lymphoma grade I and II
- Presenting with an episode of progressive disease, following 1-5 prior treatments (with either radiation, chemotherapy or rituximab).
You may not qualify if:
- Patients that failed to respond to previous rituximab treatment, or relapsed within 6 months of the first rituximab infusion
- Patients known to have an allergic reaction to rituximab or murine derived proteins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CTI BioPharmalead
Study Sites (38)
Arizona Clinical Research Center
Tucson, Arizona, 85712, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
Kenmar Research Institute
Los Angeles, California, 90057, United States
Rocky Moutain Cancer Center
Denver, Colorado, 80218, United States
Pasco, Hernando Oncology Associates, P.A.
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Orange Park Cancer Center
Orange Park, Florida, 32073, United States
University of Chicago Medical Center Hematology / Oncology
Chicago, Illinois, 60637, United States
Illinois Masonic Cancer Center
Chicago, Illinois, 60657, United States
Edward Cancer Center
Naperville, Illinois, 60540, United States
Hope Center
Terre Haute, Indiana, 47802, United States
Commonwealth Hematology/Oncology
Danville, Kentucky, 40422, United States
New England Hematology / Oncology Associates
Wellesley, Massachusetts, 02481, United States
St. Joseph Oncology
Saint Joseph, Missouri, 64507, United States
Christian Hospital
St Louis, Missouri, 63136, United States
St. Johns Mercy Medical Center
St Louis, Missouri, 63141, United States
Hematology - Oncology Centers of N. Rockies
Billings, Montana, 59101, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
East Orange VA Medical Center
East Orange, New Jersey, 07018, United States
Hematology Oncology Associates of NJ
Paramus, New Jersey, 07652, United States
Summit Medical Group/Overlook Onc Center
Summit, New Jersey, 07901, United States
New Mexico Oncology / Hematology
Albuquerque, New Mexico, 87109, United States
HemOnCare, P.C.
Brooklyn, New York, 11235, United States
Glens Falls Cancer Center
Glens Falls, New York, 12801, United States
North Shore - Long Island Jewish Health System
New Hyde Park, New York, 11040, United States
New York University
New York, New York, 10016, United States
Upstate NY Cancer Research
Rochester, New York, 14623, United States
South Shore Hematology-Oncology Associates
Rockville Centre, New York, 11570, United States
Clinworks, Inc
Charlotte, North Carolina, United States
Private Practice
Canton, Ohio, 44718, United States
Blair Medical Associates
Altoona, Pennsylvania, 16601, United States
Lancaster Cancer Center, LTD
Lancaster, Pennsylvania, 17605, United States
Santee Hematology Oncology
Sumter, South Carolina, 29150, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Central Utah Medical Clinic Hematology-Oncology
Provo, Utah, 84604, United States
Oncology of Wisconsin
Glendale, Wisconsin, 53212, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Rhinelander Regional Medical Group Onc.
Rhinelander, Wisconsin, 54501, United States
Related Publications (1)
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
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2003
First Posted
May 12, 2003
Study Start
January 1, 2005
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
January 19, 2015
Record last verified: 2013-05