335
Participants
Start Date
July 31, 2004
Primary Completion Date
June 30, 2010
Study Completion Date
June 30, 2010
FluCAM [Fludara + Campath]
"Phase A: Escalating Doses of alemtuzumab (Campath) Alone~Day 1: alemtuzumab 3 mg intravenously (IV) over 2 hours.~Day 2: alemtuzumab 10 mg IV over 2 hours if 3 mg was tolerated, else repeat 3 mg daily until tolerated.~Day 3: alemtuzumab 30 mg IV over 2 hours if 10 mg was tolerated, else repeat 10 mg daily until tolerated.~Participants were allowed 3-14 days to escalate to 30 mg. Once 30 mg was tolerated, the participant had to begin Phase B within 7 days.~Phase B: FluCAM~Cycle 1: Days 1,2,3 fludarabine phosphate administered at 30 mg/m\^2 over 30 minutes IV, followed within 1 hour by alemtuzumab 30 mg IV over 2 hours. A similar schedule is set for Cycles 2 through 6; duration of alemtuzumab infusions vary from 2-6 hours. Each 28-day period is 1 cycle. Fludarabine phosphate dosage is based on participants' body surface area at the beginning of each cycle. FluCAM administered up to a maximum of 6 cycles, based upon participants' response to therapy and toxicity."
fludarabine phosphate
Fludarabine phosphate (Fludara) is administered at a dose of 25 mg/m\^2 IV over 15 to 30 minutes daily for 5 consecutive days (days 1 through 5) every 28 days (per package instructions). Each 28-day period is 1 cycle. The dose of fludarabine phosphate will be based on the participant's body surface area as calculated at the beginning of each cycle. Participants treated with fludarabine phosphate up to a maximum of 6 cycles, based upon their response to therapy and toxicity.
Universitat Wien AKH, Innere Medizin I, Vienna
"Multiprofile Hospital for Active Treatment Alexandrovska", Sofia
National Center for Heamtology and Transfusiology, Sofia
UMHAT St. Georgi, Hematology Clinic, Plovdiv
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven
Medizinische Universitatsklinik Graz, Graz
Multiprofile Hospital for Active Treatment, St. Marina, Varna
Clinical Hospital Merkur, Zagreb
University Hospital Dubrava, Zagreb
"Laikon General Hospital, University of Athens", Goudi
Charite-Universitatsmedizin Berlin Campus Benjamin-Franklin, Berlin
Charite Universitatsklinikum der Humboldt-Universitat zu Berlin, Berlin
Unita Operativa di Medicina Generale Reumatologia e Oncoematologia, Milan
Khmelnitskiy Regional Hospital, Hematology Department, Khmelnitskiy
Florida Cancer Specialists, Fort Myers
City Clinical Hospital #4, Regional Hematology Center, Dnipro
Klinikum der Universitat zu Koln, Klinik 1 fur Innere Medizin, Cologne
Clinical Hospital Center Rijeka, Department of Haematology, Rijeka
CHRU - Hopital Claude Huriez, Lille
Kharkov Regional Clinical Oncology Center, Department of Hematology, Kharkiv
Robert-Bosch Krankenhaus GmbH, Stuttgart
Cherkasskly Oncology Dispensary, Cherkasy
Lviv National Medical University named Danilo Galytcky, Lviv
Donetsk State Medical University, Donetsk
"U.O. Oncologia Medica Azienda Ospedaliera Pugliese-Ciaccio", Cantanzaro
"GU Main Military Clinical Hospital named after acad. N.N.Burdenko of MO of Russia, Haematology Centre 3", Moscow
"GOUVPO Saint-Petersburg State Medical University named after acad I.P.Pavlov of Roszdrav, Bone Marrow Transplantology Clinic", Saint Petersburg
"Saint-Petersburg GUZ City Hospital #31 3, Dynamo Prospect", Saint Petersburg
"State Healthcare Department Sverdlovsk Regional Clinical Hospital #1,", Yekaterinburg
Cancer Care Manitoba, Winnipeg
Hopital Notre-Dame du CHUM, Montreal
"Istituto di Ematologia Dipartmento di Biotechnologie Celluari ed Ematologia, Universita di Roma La Sapienza", Rome
Klinika Hematologii i Transplantacji Szpiku, Katowice
Klinika Hematologii AM, Lodz
Klinika Hematologii Pomorskiej Akademii Medycznej w Szczecinie, Szczecin
Katedra i Klinika Hamatologii, Onkologii I Chorob Wewnetrznych AM, Warsaw
Klinika Hematologii, Nowotworow Krwii 1 Transplantacji Szpiku, Wroclaw
Hospital de Santa Maria Servico de Hematologia Clinica/Hospital de dia de Hematologia, Lisbon
Hospital de Sao Teotonio, Servico de Hematologia/Hosptial de Dia Oncologico, Viseu
Institutol Clinic Fundeni, Clinica Heamtologie, Bucharest
University Hospital, Dept. of Hematology, Lund
Orebro University Hospital, Dep. of Medicine, Örebro
Universitetssjukhuset, Örebro
Medicin kliniken/Hematologsektionen, Sundsvall
Akademiska sjukhuset, Uppsala
Institute of Oncology AMS of Ukraine, Kiev
Institute of Hematology and Transfusiology AMS of Ukraine, City Clinical Hospital #9, Kiev
Scientific Centre for Radiation Medicine AMS of Ukraine, Dept of Hematology and Transplantology, Kyiv
Genzyme, a Sanofi Company
INDUSTRY