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MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5

R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4

\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.

Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0

\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0

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

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)

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

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

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

liposomial cytarabine

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

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

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

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

whole brain radiotherapy

Andrés JM Ferreri, MD

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.

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

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

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)

International Extranodal Lymphoma Study Group (IELSG)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement	NCT02329080	Diffuse Large B...	Methotrexate Rituximab Cytarabine Thiotepa liposomial cyta... Etoposide Ifosfamide Carmustine whole brain rad...	18 Years - 70 Years	International Extranodal Lymphoma Study Group (IELSG)
New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement	NCT02329080	Diffuse Large B...	Methotrexate Rituximab Cytarabine Thiotepa liposomial cyta... Etoposide Ifosfamide Carmustine whole brain rad...	18 Years - 70 Years	International Extranodal Lymphoma Study Group (IELSG)

Spots Global Cancer Trial Database for liposomial cytarabine