77
Participants
Start Date
November 30, 2011
Primary Completion Date
July 31, 2017
Study Completion Date
December 31, 2018
Ofatumumab
1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles
Etoposide
60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles
Ifosfamid
1500mg/m2 or 1000mg/m2 (patients \>/=60 years), IV, daily over 1 hour, on 1-5 days of each 21-day cycle, maximum 6 cycles
Mesna
300mg/m2 or 200mg/m2 (patients \>/=60 years), IV, over 1 hour, mixed with ifosfamid then 900mg/m2 or 600mg/m2 (patients \>/=60 years)over 12 hour or by local practice, on 1-5 days of each 21 day cycle, maximum 6 cycles
Cytarabine
2g/m2 or 0,5-1g/m2 (patients \>/= 60 years), IV, over 3 hours, 12 hourly (total of 4 doses), on days 1-2 of each 21 day cycle, maximum 6 cycles
Methotrexate
12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles
Leukovorin
15mg, po 24 hours after methotrexate it
Granulocyte-Colony Stimulating Factor
5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC\>1.0x109/l
Dolnośląskie Centrum Transplantacji Komórkowych, Wroclaw
Instytut Hematologii i Transfuzjologii, Warsaw
Centrum Onkologii - Istytut im. M.Sklodowskiej-Curie, Warsaw
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. ks. Bronisława Markiewicza, Brzozów
Uniwersyteckie Cenrum Medyczne, Gdansk
Szpital Morski im. PCK Oddz. Onkologii i Radioterapii, Gdynia
Klinika Transplantacji Szpiku i Onkohematologii; Centrum Onkologii Instytut im. M.Sklodowskiej-Curie, Oddz. w Gliwicach, Gliwice
Oddz. Hematologii, Samodzielny Publiczny ZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn
Polish Lymphoma Research Group
NETWORK