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

Lymphoma, Follicular Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00060671
• Other study ID #: AZA III 02
• Status: Terminated
• Phase: Phase 3
• First received: May 9, 2003
• Last updated: January 15, 2015
• Start date: January 2005
• Est. completion date: January 2006

Study information

• Verified date: May 2013
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00062361

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 800
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Low-Grade
• Lymphoma, Mixed-Cell, Follicular
• Lymphoma, Non-Hodgkin
• Lymphoma, Small Cleaved-Cell, Follicular

Intervention

Drug:
• rituximab

• Pixantrone (BBR 2778)

Locations

Country	Name	City	State
United States	New Mexico Oncology / Hematology	Albuquerque	New Mexico
United States	Blair Medical Associates	Altoona	Pennsylvania
United States	Hematology - Oncology Centers of N. Rockies	Billings	Montana
United States	HemOnCare, P.C.	Brooklyn	New York
United States	Private Practice	Canton	Ohio
United States	Clinworks, Inc	Charlotte	North Carolina
United States	Illinois Masonic Cancer Center	Chicago	Illinois
United States	University of Chicago Medical Center Hematology / Oncology	Chicago	Illinois
United States	Commonwealth Hematology/Oncology	Danville	Kentucky
United States	Rocky Moutain Cancer Center	Denver	Colorado
United States	East Orange VA Medical Center	East Orange	New Jersey
United States	Oncology of Wisconsin	Glendale	Wisconsin
United States	Glens Falls Cancer Center	Glens Falls	New York
United States	Great Falls Clinic	Great Falls	Montana
United States	Sutter Health Western Division Cancer Research Group	Greenbrae	California
United States	Lancaster Cancer Center, LTD	Lancaster	Pennsylvania
United States	Kenmar Research Institute	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	The West Clinic	Memphis	Tennessee
United States	Edward Cancer Center	Naperville	Illinois
United States	North Shore - Long Island Jewish Health System	New Hyde Park	New York
United States	Pasco, Hernando Oncology Associates, P.A.	New Port Richey	Florida
United States	New York University	New York	New York
United States	Ocala Oncology Center	Ocala	Florida
United States	Orange Park Cancer Center	Orange Park	Florida
United States	Hematology Oncology Associates of NJ	Paramus	New Jersey
United States	Central Utah Medical Clinic Hematology-Oncology	Provo	Utah
United States	Rhinelander Regional Medical Group Onc.	Rhinelander	Wisconsin
United States	Upstate NY Cancer Research	Rochester	New York
United States	South Shore Hematology-Oncology Associates	Rockville Centre	New York
United States	St. Joseph Oncology	St Joseph	Missouri
United States	Christian Hospital	St Louis	Missouri
United States	St. Johns Mercy Medical Center	St. Louis	Missouri
United States	Summit Medical Group/Overlook Onc Center	Summit	New Jersey
United States	Santee Hematology Oncology	Sumter	South Carolina
United States	Hope Center	Terre Haute	Indiana
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	New England Hematology / Oncology Associates	Wellesley	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 o

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	For 5 years post treatment