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

Tracking Information
First Received Date ^ICMJE	May 9, 2003
Last Updated Date	October 28, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00060671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma
Official Title ^ICMJE	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)
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Lymphoma, Follicular Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular Lymphoma, Low-Grade
Intervention ^ICMJE	Drug: rituximab Drug: Pixantrone (BBR 2778)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	800
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00060671
Responsible Party
Study ID Numbers ^ICMJE	AZA III 02
Study Sponsor ^ICMJE	Cell Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cell Therapeutics
Verification Date	October 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP