Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma.
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.


BACKGROUND
NCT01321541.
4th Department of Internal Medicine - Hematology, Charles University Hospital & Faculty of Medicine, Hradec Králové, Czech Republic.
David
D
Belada
UMHAT "Sveti Georgi", Plovdiv, Clinical Haematology Clinic, Plovdiv, Bulgaria.
Pencho
P
Georgiev
Cancer Center of Kansas, Wichita, KS, USA.
Shaker
S
Dakhil
Blue Ridge Cancer Care, Roanoke, VA, USA.
Lowell F
LF
Inhorn
Rocky Mountain Cancer Center, Boulder, CO, USA.
David
D
Andorsky
Highlands Oncology Group, Fayetteville, AR, USA.
J Thaddeus
JT
Beck
Joe Arrington Cancer Research & Treatment Center, Lubbock, TX, USA.
Donald
D
Quick
St George's Healthcare NHS Trust, Tooting, London, UK.
Ruth
R
Pettengell
CTI Biopharma Corp., Seattle, WA, USA.
Robert
R
Daly
CTI Biopharma Corp., Seattle, WA, USA.
James P
JP
Dean
Institut de Recherches Internationales Servier, Suresnes, France.
Mariya
M
Pavlyuk
Institut de Recherches Internationales Servier, Suresnes, France.
Nelly
N
Failloux
University Hospital of Cologne, Cologne, Germany.
Kai
K
Hübel
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage / Q000009:adverse effects; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D012107:Research Design; D000069283:Rituximab / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
D007546:Isoquinolines; D003841:Deoxycytidine; D000069283:Rituximab; C086548:pixantrone; D000093542:Gemcitabine
DLBCL; aggressive non-Hodgkin lymphoma; gemcitabine; pixantrone; relapse; rituximab