187
Participants
Start Date
February 27, 2012
Primary Completion Date
July 11, 2016
Study Completion Date
July 11, 2016
MEDI-551 2 mg/kg
MEDI-551 at the assigned dose will be administered via Intravenous (IV) infusion. Subjects will receive 3 cycles of M-ICE or M-DHAP unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).
Rituximab
Rituximab at 375 mg/m2 will be administered via IV infusion 2 days before the start of Cycle 1 and on Day 1 of each cycle. The infusion time for rituximab will be 50 400 mg/hr, depending on subject's tolerance. Subjects will receive 3 cycles of Rituximab with Ice (R ICE) or Rituximab with DHAP (R-DHAP) unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).
ICE
ICE will be administered via IV infusion as follows: ifosfamide 5 g/m2 continuously for 24 hours with mesna on Days 2 and 3; carboplatin AUC=5 mg/mL x min \[800 mg maximum) on Day 2; etoposide 100 mg/m2 on Days 1, 2, and 3) in 21-day cycles.
DHAP
DHAP will be administered via IV infusion as follows: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m2 continuously for 24 hours on Day 1 of dosing cycle; cytarabine 2 g/m2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
Autologous Stem Cell Transplant (ASCT)
Subjects who achieve CR or PR will undergo stem cell harvest and autologous stem cell transplantation (ASCT) following standard institutional protocols.
MEDI-551 4 mg/kg
MEDI-551 at the assigned dose will be administered via Intravenous (IV) infusion. Subjects will receive 3 cycles of M-ICE or M-DHAP unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).
Research Site, The Bronx
Research Site, Berlin
Research Site, Cadiz
Research Site, Brno
Research Site, Prague
Research Site, Marseille
Research Site, Marseille
Research Site, Girona
Research Site, Hershey
Research Site, Philadelphia
Research Site, Lublin
Research Site, Baltimore
Research Site, Morgantown
Research Site, Madrid
Research Site, Majadahonda
Research Site, San Sebastián de los Reyes
Research Site, Málaga
Research Site, Charleston
Research Site, Atlanta
Research Site, Pamplona
Research Site, Haifa
Research Site, Libourne
Research Site, Bordeaux
Research Site, Pessac
Research Site, Birmingham
Research Site, Izmir
Research Site, Izmir
Research Site, Salamanca
Research Site, Tours
Research Site, Knoxville
Research Site, Talas
Research Site, Seville
Research Site, Seville
Research Site, Hazard
Research Site, Newark
Research Site, Sylvania
Research Site, Malatya
Research Site, Dayton
Research Site, Valencia
Research Site, Valencia
Research Site, Valencia
Research Site, Milwaukee
Research Site, Mainz
Research Site, Kurupelit
Research Site, Minneapolis
Research Site, Rochester
Research Site, Fargo
Research Site, St Louis
Research Site, Kansas City
Research Site, Tel Aviv
Research Site, Frankfurt
Research Site, Kansas City
Research Site, Westwood
Research Site, Lafayette
Research Site, Shreveport
Research Site, Le Mans
Research Site, Tübingen
Research Site, Dallas
Research Site, Rouen
Research Site, Houston
Research Site, Ashkelon
Research Site, Lubbock
Research Site, München
Research Site, Sylmar
Research Site, Burbank
Research Site, Palm Springs
Research Site, Würzburg
Research Site, Saint Petersburg
Research Site, Saint Petersburg
Research Site, Nizhny Novgorod
Research Site, Saint John
Research Site, Halifax
Research Site, Greenfield Park
Research Site, Budapest
Research Site, Debrecen
Research Site, Győr
Research Site, Kaposvár
Research Site, Jerusalem
Research Site, Gdynia
Research Site, Barcelona
Research Site, L'Hospitalet de Llobregat
Lead Sponsor
MedImmune LLC
INDUSTRY