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

Phase 3

Terminated

• Conditions: Lymphoma, Mixed-Cell, Follicular; Lymphoma, Low-Grade; Lymphoma, Follicular; Lymphoma, 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.

Study Timeline

• Study First Submitted: 2003-05-09
• Study First Submitted QC: 2003-05-09
• Study First Posted: 2003-05-12
• Study Start: 2005-01
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2013-05
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

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

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

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