Overview

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

Status:
Terminated
Trial end date:
2006-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CTI BioPharma
Treatments:
Antibodies
Pixantrone
Rituximab
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.