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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)

Phase 3
18 Years
Not Enrolling
Lymphoma, Follicular, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular, Lymphoma, Low-Grade

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Trial Information

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)

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

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.

Inclusion 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.

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

January 2006

Related Keywords:

  • Lymphoma, Follicular
  • Lymphoma, Mixed-Cell, Follicular
  • Lymphoma, Small Cleaved-Cell, Follicular
  • Lymphoma, Low-Grade
  • Pixantrone
  • BBR 2778
  • chemotherapy
  • DNA Intercalator
  • Anthracycline
  • Rituximab
  • Rituxan
  • Mabthera
  • monoclonal antibody
  • antibody
  • NHL
  • Non-Hodgkin's lymphoma
  • indolent
  • low grade
  • Novuspharma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



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