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

PHASE2CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

August 31, 2019

Study Completion Date

March 22, 2024

Conditions
Diffuse Large B-cell Lymphoma
Interventions
DRUG

Methotrexate

methotrexate 3.5 g/m2 on day 1 courses 1, 2,3 of MATRIX regimen

DRUG

Rituximab

Rituximab 375 mg/m2 as conventional IV infusion on day 0 courses 1, 2,3 (MATRIX regimen) and on day 1 courses 4,5,6 (R-ICE)

DRUG

Cytarabine

Cytarabine 2 g/m2 every 12 hours, in 3-hr infusion on days 2,3 courses 1, 2,3 (MATRIX regimen)

DRUG

Thiotepa

Thiotepa 30 mg/m2 in 30 minutes infusion on day 4 courses 1, 2,3 (MATRIX regimen) and 5 mg/kg in 250 ml of saline sol. in 2-hrs infusion every 12 hours on day -5 and -4 of conditioning and ASCT

DRUG

liposomial cytarabine

Intrathecal liposomial cytarabine 50 mg on day 5 courses 1, 2,3 (MATRIX regimen) and on day 4 courses 4,5,6 (R-ICE)

DRUG

Etoposide

Etoposide 100 mg/m2/d in 500 mL saline sol. in 30 minutes on day 1-2-3 courses 4,5,6 (R-ICE)

DRUG

Ifosfamide

Ifosfamide 5 g/m2 in 1.000 mL saline sol. in 24-hour infusion on day 2 courses 4,5,6 (R-ICE)

DRUG

Carmustine

BCNU (carmustine) 400 mg/m2 in 500 mL glucose 5% sol. in 1-hr infusion on day-6 of conditioning and ASCT

RADIATION

whole brain radiotherapy

whole-brain irradiation 36 Gy + tumor- bed boost 10 Gy in patients with residual disease in the parenchymal brain/cerebellum.

Trial Locations (36)

Unknown

Facultni nemocnice, Brno

FNKV (Facultni Nemocnice Kralovske Vinohrady), Prague

Vseobecna facultni nemocnice v Praze, Prague

Spedali Civili, Brescia

UO Ematologia e CTMO, PO Businco, Cagliari

IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

UO Ematoliga Ospedale dell'Angelo, Mestre

San Raffaele H Scientific Institute, Milan

Istituto Nazionale Tumori, Milan

Ospedale Maggiore Policlinico, Milan

AOU Policlinico di Modena, Modena

SCDU Ematologia, Novara

Ematologia ed Immunologia Clinica - AO di Padova, Padua

UO Oncoematologia Ospedale Tortora, Pagani

Villa Sofia - Cervello, Palermo

Ematologia AOU, Parma

Ematologia Ospedale S.Maria delle Croci, Ravenna

A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia, Reggio Calabria

Arcispedale Santa Maria Nuova, Azienda Ospedaliera di Reggio Emilia, Reggio Emilia

Ematologia Università La Sapienza, Roma

IRCCS Istituto Regina Elena (IFO), Roma

Policlinico Universitario Campus Bio-Medico, Rome

IRCCS Casa Sollievo Della Sofferenza, San Giovanni Rotondo

AOU Senese, Siena

AO S.Maria di Terni, Terni

SC Ematologia AO Città della Salute e della Scienza, Torino

UO Ematologia Ospedale Panico, Tricase

AOU Santa Maria della Misericordia, Udine

UOC Ematologia Policlinico Rossi, Verona

Ematologia Ospedale S. Bortolo, Vicenza

Erasmus MC, Rotterdam

Beatson Cancer Center, Glasgow

Liverpool Aintree, Liverpool

UCLH University College London Hospitals NHS foundation trust, London

The Christie Hospital, Manchester

Southampton General Hospital, Southampton

All Listed Sponsors
lead

International Extranodal Lymphoma Study Group (IELSG)

OTHER

NCT02329080 - New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement | Biotech Hunter | Biotech Hunter