High-dose Sequential Chemoimmunotherapy for B-cell Lymphomas With Central Nervous System Involvement

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
B-cell Lymphomas
Interventions
DRUG

High-dose sequential chemotherapy and autologous transplant

Two courses of methotrexate 3.5 g/mq day 1 and cytarabine 2 g/mq twice a day, for two days, Rituximab 375 mg/mq days 3 \& 11 and Intrathecal liposomal cytarabine 50 mg day 6(Phase I) followed in case of response by cyclophosphamide 7 g/mq plus Rituximab 375 mg/mq and Intrathecal liposomal cytarabine 50 mg Leukapheresis A and cryopreservation (Phase II), Cytarabine 2 g/mq twice a day for 4 days, Rituximab 375 mg/m2 and Reinfusion of stem cells (Phase III), etoposide 2 g/mq, Intrathecal liposomal cytarabine 50 mg (Phase IV) and high-dose Thiotepa-BCNU supported by autologous stem cell transplant (Phase V), and whole-brain radiotherapy in patients who do not achieve a complete remission after chemotherapy (Phase VI)

Trial Locations (1)

20132

San Raffaele Scientific Institute, Milan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mundipharma Pte Ltd.

INDUSTRY

lead

Andrés José Maria Ferreri

OTHER