Last updated on March 2019

New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement


Brief description of study

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 Study 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

Clinical Study Identifier: NCT02329080

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Facultni nemocnice

Brno, Czech Republic

Vseobecna facultni nemocnice v Praze

Praha, Czech Republic

Spedali Civili

Brescia, Italy

SCDU Ematologia

Novara, Italy

Villa Sofia - Cervello

Palermo, Italy

Ematologia AOU

Parma, Italy

AOU Senese

Siena, Italy

AO S.Maria di Terni

Terni, Italy

Erasmus MC

Rotterdam, Netherlands

Beatson Cancer Center

Glasgow, United Kingdom

Liverpool Aintree

Liverpool, United Kingdom

The Christie Hospital

Manchester, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

IRCCS Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Italy

Recruitment Status: Closed


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