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

Primary Purpose

Lymphoma, Follicular, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rituximab
Pixantrone (BBR 2778)
Sponsored by
CTI BioPharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Follicular focused on measuring Pixantrone, BBR 2778, chemotherapy, DNA Intercalator, Anthracycline, Rituximab, Rituxan, Mabthera, monoclonal antibody, antibody, NHL, Non-Hodgkin's lymphoma, indolent, low grade, Novuspharma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Clinical Research Center
  • Sutter Health Western Division Cancer Research Group
  • Kenmar Research Institute
  • Rocky Moutain Cancer Center
  • Pasco, Hernando Oncology Associates, P.A.
  • Ocala Oncology Center
  • Orange Park Cancer Center
  • University of Chicago Medical Center Hematology / Oncology
  • Illinois Masonic Cancer Center
  • Edward Cancer Center
  • Hope Center
  • Commonwealth Hematology/Oncology
  • New England Hematology / Oncology Associates
  • St. Joseph Oncology
  • Christian Hospital
  • St. Johns Mercy Medical Center
  • Hematology - Oncology Centers of N. Rockies
  • Great Falls Clinic
  • East Orange VA Medical Center
  • Hematology Oncology Associates of NJ
  • Summit Medical Group/Overlook Onc Center
  • New Mexico Oncology / Hematology
  • HemOnCare, P.C.
  • Glens Falls Cancer Center
  • North Shore - Long Island Jewish Health System
  • New York University
  • Upstate NY Cancer Research
  • South Shore Hematology-Oncology Associates
  • Clinworks, Inc
  • Private Practice
  • Blair Medical Associates
  • Lancaster Cancer Center, LTD
  • Santee Hematology Oncology
  • The West Clinic
  • Central Utah Medical Clinic Hematology-Oncology
  • Oncology of Wisconsin
  • Marshfield Clinic
  • Rhinelander Regional Medical Group Onc.

Outcomes

Primary Outcome Measures

Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone

Secondary Outcome Measures

To compare BBR 2778 + rituximab versus rituximab for:
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

Full Information

First Posted
May 9, 2003
Last Updated
January 15, 2015
Sponsor
CTI BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT00060671
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CTI BioPharma

4. Oversight

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
Pixantrone (BBR 2778)
Primary Outcome Measure Information:
Title
Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone
Time Frame
For 5 years post treatment
Secondary Outcome Measure Information:
Title
To compare BBR 2778 + rituximab versus rituximab for:
Description
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
Time Frame
For 5 years post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Sutter Health Western Division Cancer Research Group
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Kenmar Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Rocky Moutain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Pasco, Hernando Oncology Associates, P.A.
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Orange Park Cancer Center
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
University of Chicago Medical Center Hematology / Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Illinois Masonic Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Edward Cancer Center
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Hope Center
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Commonwealth Hematology/Oncology
City
Danville
State/Province
Kentucky
ZIP/Postal Code
40422
Country
United States
Facility Name
New England Hematology / Oncology Associates
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
St. Joseph Oncology
City
St Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Christian Hospital
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
St. Johns Mercy Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hematology - Oncology Centers of N. Rockies
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
East Orange VA Medical Center
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Hematology Oncology Associates of NJ
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Summit Medical Group/Overlook Onc Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
New Mexico Oncology / Hematology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
HemOnCare, P.C.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Glens Falls Cancer Center
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
North Shore - Long Island Jewish Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Upstate NY Cancer Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
South Shore Hematology-Oncology Associates
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Clinworks, Inc
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Private Practice
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Blair Medical Associates
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
Lancaster Cancer Center, LTD
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17605
Country
United States
Facility Name
Santee Hematology Oncology
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Central Utah Medical Clinic Hematology-Oncology
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Oncology of Wisconsin
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Rhinelander Regional Medical Group Onc.
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States

12. IPD Sharing Statement

Citations:
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
Results Reference
result

Learn more about this trial

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

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