Non Hodgkin Lymphoma Clinical Trial
Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin’s Lymphoma
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.
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:
Patients treated with both pixantrone and rituximab, in combination
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.
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).
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 36 Locations for this study
Tucson Arizona, 85712, United States
Greenbrae California, 94904, United States
Los Angeles California, 90057, United States
Denver Colorado, 80218, United States
New Port Richey Florida, , United States
Ocala Florida, 34474, United States
Orange Park Florida, 32073, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60657, United States
Naperville Illinois, 60540, United States
Terre Haute Indiana, 47802, United States
Danville Kentucky, 40422, United States
Wellesley Massachusetts, 02481, United States
St Joseph Missouri, 64507, United States
St Louis Missouri, 63136, United States
St. Louis Missouri, 63141, United States
Billings Montana, 59101, United States
Great Falls Montana, 59405, United States
East Orange New Jersey, 07018, United States
Paramus New Jersey, 07652, United States
Summit New Jersey, 07901, United States
Albuquerque New Mexico, 87109, United States
Brooklyn New York, 11235, United States
Glens Falls New York, 12801, United States
New Hyde Park New York, 11040, United States
New York New York, 10016, United States
Rochester New York, 14623, United States
Rockville Centre New York, 11570, United States
Charlotte North Carolina, , United States
Canton Ohio, 44718, United States
Altoona Pennsylvania, 16601, United States
Lancaster Pennsylvania, 17605, United States
Sumter South Carolina, 29150, United States
Memphis Tennessee, 38120, United States
Provo Utah, 84604, United States
Glendale Wisconsin, 53212, United States
Marshfield Wisconsin, 54449, United States
Rhinelander Wisconsin, 54501, United States
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.