Clinical trial NCT00060671: Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lymphoma, Follicular
Lymphoma, Mixed-Cell, Follicular
Lymphoma, Small Cleaved-Cell, Follicular
Lymphoma, Low-Grade
Keywords: Pixantrone
BBR 2778
chemotherapy
DNA Intercalator
Anthracycline
Rituximab
Rituxan
Mabthera
monoclonal antibody
antibody
NHL
Non-Hodgkin's lymphoma
indolent
low grade
Novuspharma
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2003-05-12
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone
timeFrame: For 5 years post treatment
Secondary outcomes:
measure: To compare BBR 2778 + rituximab versus rituximab for:
timeFrame: For 5 years post treatment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Greenbrae
country: United States
facility: Sutter Health Western Division Cancer Research Group
state: California
city: Los Angeles
country: United States
facility: Kenmar Research Institute
state: California
city: Denver
country: United States
facility: Rocky Moutain Cancer Center
state: Colorado
city: New Port Richey
country: United States
facility: Pasco, Hernando Oncology Associates, P.A.
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orange Park
country: United States
facility: Orange Park Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center Hematology / Oncology
state: Illinois
city: Chicago
country: United States
facility: Illinois Masonic Cancer Center
state: Illinois
city: Naperville
country: United States
facility: Edward Cancer Center
state: Illinois
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: Danville
country: United States
facility: Commonwealth Hematology/Oncology
state: Kentucky
city: Wellesley
country: United States
facility: New England Hematology / Oncology Associates
state: Massachusetts
city: St Joseph
country: United States
facility: St. Joseph Oncology
state: Missouri
city: St Louis
country: United States
facility: Christian Hospital
state: Missouri
city: St. Louis
country: United States
facility: St. Johns Mercy Medical Center
state: Missouri
city: Billings
country: United States
facility: Hematology - Oncology Centers of N. Rockies
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: East Orange
country: United States
facility: East Orange VA Medical Center
state: New Jersey
city: Paramus
country: United States
facility: Hematology Oncology Associates of NJ
state: New Jersey
city: Summit
country: United States
facility: Summit Medical Group/Overlook Onc Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology / Hematology
state: New Mexico
city: Brooklyn
country: United States
facility: HemOnCare, P.C.
state: New York
city: Glens Falls
country: United States
facility: Glens Falls Cancer Center
state: New York
city: New Hyde Park
country: United States
facility: North Shore - Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Rochester
country: United States
facility: Upstate NY Cancer Research
state: New York
city: Rockville Centre
country: United States
facility: South Shore Hematology-Oncology Associates
state: New York
city: Charlotte
country: United States
facility: Clinworks, Inc
state: North Carolina
city: Canton
country: United States
facility: Private Practice
state: Ohio
city: Altoona
country: United States
facility: Blair Medical Associates
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Cancer Center, LTD
state: Pennsylvania
city: Sumter
country: United States
facility: Santee Hematology Oncology
state: South Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Provo
country: United States
facility: Central Utah Medical Clinic Hematology-Oncology
state: Utah
city: Glendale
country: United States
facility: Oncology of Wisconsin
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Rhinelander
country: United States
facility: Rhinelander Regional Medical Group Onc.
state: Wisconsin
Study officials:
References:
citation: 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