29
Participants
Start Date
November 30, 2007
Primary Completion Date
April 30, 2011
Study Completion Date
April 30, 2011
inotuzumab ozogamicin
IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
rituximab
IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
rituximab
intravenous rituximab at a dose of 375 mg/m2 on day 1
cyclophosphamide
intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
vincristine
intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
prednisone/prednisolone
oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
mitoxantrone
mitoxantrone 10 mg/m2 intravenous on day 2
fludarabine
fludarabine 25 mg/m2 intravenous on days 2 through 4
dexamethasone
oral dexamethasone 20 mg/day on days 1-5
Wits Donald Gordon Clinical Trial Site, Johannesburg
Oncologisch Centrum GZA - Location St. Augustinus, Wilrijk
Universitair Ziekenhuis Gent, Ghent
Avi Einzing, MD, The Bronx
Advanced Oncology Associates, Armonk
Advanced Oncology Associates, New Rochelle
Marc Zimmerman, MD, Pomona
The Harry & Jeanette Weinberg Cancer Inst at Franklin Square, Baltimore
Divisione di Ematologia - Fondazione IRCCS Policlinico San Matteo, Pavia
Hospital de La Princesa, Madrid
Hospital Universitario Puerta de Hierro, Majadahonda
Hematology and Oncology Associates at Bridgepoint, Tupelo
Hematology and Oncology Associates, Corinth
Hematology and Oncology Associates, Columbus
Deaconess Clinic, Evansville
Newland Medical Associates, PC, Southfield
Newland Medical Associates, Novi
Park Nicollet Frauenshuh Cancer Center, Saint Louis Park
Hospital Universitario de Nuevo Leon, Monterrey
Facey Medical Group, Mission Hills
Wenatchee Valley Medical Center, Wenatchee
Moscow Regional Research Clinical Institute named after Vladimirsky, Moscow
Jehangir Clinical Development Centre, Pune
MMF Joshi Hospital and Ratna Memorial Hospital, Pune
B. P. Poddar Hospital and Medical Research Ltd., Kolkata
Hackensack University Medical Center, Hackensack
The Cancer Center at Hackensack University Medical Center, Hackensack
Hematology Oncology Associates of Northern New Jersy, Morristown
Centro de Transplantes de medula Osea de Rosario, CETRAMOR, Rosario
Hopital Charles LeMoyne, Greenfield Park
Jewish General Hospital, Montreal
C.H.A. Enfant-Jesus, Québec
CHUS-Hopital Fleurimont, Sherbrooke
Prince of Wales Hospital, Shatin
Queen Mary Hospital, Hong Kong
Instytut Hematologii i Transfuzjologii, Warsaw
Hospitais Da Universidade De Coimbra, Coimbra
Yonsei University Health System-Severance Hospital, Seoul
Hospital Santa Creu I Sant Pau, Barcelona
Lead Sponsor
Collaborators (1)
UCB Pharma
INDUSTRY
Pfizer
INDUSTRY