Spots Global Cancer Trial Database for New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement
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Trial Identification
Brief Title: New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement
Official Title: An International Phase II Trial Assessing Tolerability and Efficacy of Sequential Methotrexate-Aracytin-based Combination and R-ICE Combination, Followed by HD Chemotherapy Supported by ASCT, in Patients With Systemic B-cell Lymphoma With CNS Involvement at Diagnosis or Relapse (MARIETTA Regimen)
Study ID: NCT02329080
Conditions
Study Description
Brief Summary: This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and feasibility of a new sequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and by high-dose chemotherapy supported by ASCT.
Detailed Description: Treatment includes 6 courses of chemoimmunotherapy, the first three courses with an high dose methotrexate-based combination (MATRIX) followed by other three courses of R-ICE combination and finally a BCNU-thiotepa- containing conditioning and subsequent autologous stem cell transplantation. MATRIX (courses 1, 2, 3): Rituximab 375 mg/m2, Methotrexate 3.5 g/m2, Cytarabine 2 g/m2, Folinic rescue 15 mg/m2, Thiotepa 30 mg/m2, Intrathecal liposomial cytarabine 50 mg, rHuG-CSF 2,5 g/kg s.c. R-ICE (courses 4, 5, 6): Rituximab 375 mg/m2, Etoposide 100 mg/m2/d , Ifosfamide 5 g/m2, Intrathecal liposomial cytarabine 50 mg
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Facultni nemocnice, Brno, , Czechia
FNKV (Facultni Nemocnice Kralovske Vinohrady), Praha, , Czechia
Vseobecna facultni nemocnice v Praze, Praha, , Czechia
Spedali Civili, Brescia, , Italy
UO Ematologia e CTMO, PO Businco, Cagliari, , Italy
IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
UO Ematoliga Ospedale dell'Angelo, Mestre, , Italy
Istituto Nazionale Tumori, Milano, , Italy
Ospedale Maggiore Policlinico, Milano, , Italy
San Raffaele H Scientific Institute, Milan, , Italy
AOU Policlinico di Modena, Modena, , Italy
SCDU Ematologia, Novara, , Italy
Ematologia ed Immunologia Clinica - AO di Padova, Padova, , Italy
UO Oncoematologia Ospedale Tortora, Pagani, , Italy
Villa Sofia - Cervello, Palermo, , Italy
Ematologia AOU, Parma, , Italy
Ematologia Ospedale S.Maria delle Croci, Ravenna, , Italy
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia, Reggio Calabria, , Italy
Arcispedale Santa Maria Nuova, Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, , Italy
Ematologia Università La Sapienza, Roma, , Italy
IRCCS Istituto Regina Elena (IFO), Roma, , Italy
Policlinico Universitario Campus Bio-Medico, Rome, , Italy
IRCCS Casa Sollievo Della Sofferenza, San Giovanni Rotondo, , Italy
AOU Senese, Siena, , Italy
AO S.Maria di Terni, Terni, , Italy
SC Ematologia AO Città della Salute e della Scienza, Torino, , Italy
UO Ematologia Ospedale Panico, Tricase, , Italy
AOU Santa Maria della Misericordia, Udine, , Italy
UOC Ematologia Policlinico Rossi, Verona, , Italy
Ematologia Ospedale S. Bortolo, Vicenza, , Italy
Erasmus MC, Rotterdam, , Netherlands
Beatson Cancer Center, Glasgow, , United Kingdom
Liverpool Aintree, Liverpool, , United Kingdom
UCLH University College London Hospitals NHS foundation trust, London, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Contact Details
Name: Andrés JM Ferreri, MD
Affiliation: IELSG
Role: STUDY_CHAIR
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