Date: 2017-08-02
Type of
information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: CTI BioPharma - previously known as Cell Therapeutics (USA - WA)
Product: Pixuvri® (pixantrone)
Action
mechanism:
- topoisomerase II inhibitor/monoclonal antibody. Pixuvri® is a novel aza-anthracenedione with distinct structural and physio-chemical properties. Similar to anthracyclines, Pixuvri® inhibits Topo-isomerase II but unlike anthracyclines -- rather than intercalation with DNA – Pixuvri® alkylates DNA -- forming stable DNA adducts with particular specificity for CpG-rich, hyper-methylated sites. Pixuvri® is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL .
- Rituximab is a therapeutic monoclonal antibody that binds to the CD20 antigen on the surface of normal and malignant B-cells. It then recruits the body’s natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
Disease: relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma
Therapeutic
area: Cancer - Oncology
Country: Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Slovakia, Spain, Ukraine, UK, USA
Trial
details:
- The purpose of this study is to evaluate the efficacy of pixantrone + rituximab compared to gemcitabine + rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma. Patients eligible to be enrolled in the trial had failed front line CHOP-R and were not eligible for autologous stem cell transplant (ASCT) (2nd line) or failed ASCT (3rd or 4th line). (NCT01321541)
Latest
news:
- • On August 2, 2017, CTI BioPharma announced the completion of enrollment in the Phase 3 PIX306 trial of Pixvuri® (pixantrone). The PIX306 trial is evaluating Pixvuri® combined with rituximab in comparison to that of rituximab combined with gemcitabine in patients with aggressive B-cell non-Hodgkin lymphoma ( NHL ).
- The trial is being conducted as a post-authorization requirement of conditional marketing authorization. If positive, the results from this trial could support broader indications. Top-line results are event-driven and are expected in the first half of 2018.
Is
general: Yes
