Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
27093976
DOI
10.2217/fon-2016-0137
Knihovny.cz E-resources
- Keywords
- DLBCL, aggressive non-Hodgkin lymphoma, gemcitabine, pixantrone, relapse, rituximab,
- MeSH
- Deoxycytidine administration & dosage adverse effects analogs & derivatives MeSH
- Adult MeSH
- Gemcitabine MeSH
- Isoquinolines administration & dosage adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Recurrence, Local drug therapy MeSH
- Lymphoma, Non-Hodgkin drug therapy MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Rituximab administration & dosage adverse effects MeSH
- Aged MeSH
- Research Design MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Deoxycytidine MeSH
- Gemcitabine MeSH
- Isoquinolines MeSH
- pixantrone MeSH Browser
- Rituximab MeSH
UNLABELLED: We describe the rationale and design of the ongoing randomized, active-controlled, multicenter, Phase III study evaluating the efficacy of pixantrone and rituximab versus gemcitabine and rituximab in patients with diffuse large B-cell lymphoma or follicular grade 3 lymphoma, who are ineligible for high-dose chemotherapy and stem cell transplantation, and who failed front-line regimens containing rituximab. The administration schedule is pixantrone 50 mg/m(2) intravenously (iv.) or gemcitabine 1000 mg/m(2) iv. on days 1, 8 and 15, combined with rituximab 375 mg/m(2) iv. on day 1, up to six cycles. Pixantrone has a conditional European marketing approval for monotherapy in adults with multiple relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Our trial explores the efficacy of combining pixantrone with rituximab and completes postauthorization measures. TRIAL REGISTRATION NUMBER: NCT01321541.
Blue Ridge Cancer Care Roanoke VA USA
Cancer Center of Kansas Wichita KS USA
CTI Biopharma Corp Seattle WA USA
Highlands Oncology Group Fayetteville AR USA
Institut de Recherches Internationales Servier Suresnes France
Joe Arrington Cancer Research and Treatment Center Lubbock TX USA
Rocky Mountain Cancer Center Boulder CO USA
St George's Healthcare NHS Trust Tooting London UK
UMHAT Sveti Georgi Plovdiv Clinical Haematology Clinic Plovdiv Bulgaria
References provided by Crossref.org
ClinicalTrials.gov
NCT01321541
