A Phase 3 interventional study of rituximab and Pixantrone (BBR 2778) in Lymphoma, Follicular, Lymphoma, Mixed-Cell, Follicular and Lymphoma, Small Cleaved-Cell, Follicular, sponsored by CTI BioPharma. Terminated at 38 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by CTI BioPharma · Phase 3, Interventional, and Treatment
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.
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:
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 800 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →CTI BioPharma is the lead sponsor of 38 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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:
* 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
Time frame: For 5 years post treatment
This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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