Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma
|Lymphoma, Follicular Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular Lymphoma, Low-Grade||Drug: rituximab Drug: Pixantrone (BBR 2778)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
- 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 ]
- To compare BBR 2778 + rituximab versus rituximab for: [ Time Frame: For 5 years post treatment ]
- 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
|Study Start Date:||January 2005|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060671
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