92
Participants
Start Date
November 30, 2006
Primary Completion Date
December 31, 2011
Study Completion Date
August 31, 2012
Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT
"Clin A:~* CHOP-Campath (CHOP-C) for 2 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO on days +1 to +5; Campath-1H (alemtuzumab) dose escalation 3-10-20mg IV days - 2, - 1, 0 (first CHOP-C) or 30mg SC day 0 (second CHOP-C). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on days + 1 and 21 (first and second CHOP-C).~* HYPER-C-HiDAM for 2 cycles: Methotrexate 1.5gr/m2 day +1; Cyclophosphamide 300mg/m2 every 12 hours days +2-3-4; ARA-C 2gr/m2 every 12 hours days +2-3-4; G-CSF 5μcg/kg/day starting from day +5 until peripheral blood stem cell harvest~* Myeloablative regimen followed by autologous transplantation or Reduced intensity conditioning followed by allogeneic transplantation."
Clin B (CHOP- CAMPATH) Chemo-immunotherapy
"Clin B:~* CHOP-Campath (CHOP-C) for 6 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO from day +1 to day +5¸ Campath-1H (alemtuzumab) 3-10mg IV on days - 1 and 0 ( first CHOP-C course) or 10mg SC on day 0 (for the following 5 C-CHOP courses). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on day +1 of each CHOP-C course."
Azienda Ospedaliera S. Luigi, Orbassano
Azienda OspedalieraSan Giovanni Battista, Torino
Università di Torino- Azienda Ospedaliera S. Giovanni Battista, Torino
Ospedale S. Croce - Division of Hematology, Cuneo
Ospedale SS. Antonio e Biagio e Cesare Arrigo, Alessandria
Ospedale San Raffaele, Milano - Division of Hematology, Milan
IRCCS Ospedale Maggiore Policlinico di Milano, Milan
Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori, Milan
Ospedale Riuniti, Bergamo - Division of Hematology, Bergamo
Spedali Civili di Brescia, Brescia
Azienda Ospedaliera Policlinico di Verona, Verona
Ospedale Generale Regionale Bolzano, Bolzano
University of Ancona - Division of Hematology, Ancona
Ospedale San Carlo, Potenza
Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania, Catania
Policlinico Universitario Udine, Udine
Ospedale Cervello - Bone Marrow Transplantation Unit, Palermo
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER