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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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