Non Hodgkin Lymphoma Clinical Trial

Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin’s Lymphoma

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.

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Full 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:

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

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).

Exclusion criteria:

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

800

Study ID:

NCT00060671

Recruitment Status:

Terminated

Sponsor:

CTI BioPharma

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There are 36 Locations for this study

See Locations Near You

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
St 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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

800

Study ID:

NCT00060671

Recruitment Status:

Terminated

Sponsor:


CTI BioPharma

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