THE NORDIC LYMPHOMA GROUP

2006

PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA

Immunochemotherapy in Primary Central Nervous System Lymphoma with Rituximab, HD-MTX, HD-Ara C, cyclophosphamide, ifosfamide, vincristine, vindesine, temozolomide and DepoCyte induction followed by maintenance treatment in elderly patients with temozolomide.

Elisa Jacobsen Pulczynski, Denmark

Martin Erlansson, Sweden,

Outi Kuittinen, Finland,

Unn-Merete Fagerli, Norway

Sponsor:

Elisa Jacobsen Pulczynski, MD

Nordic Lymphoma Group

Department of Haematology

University Hospital Aarhus

Tage Hansens Gade 2

DK - 8000 Aarhus

Denmark

Telephone 89 49 79 36

Coordinating Investigator	Investigator	Centre	Country
Elisa Jacobsen Pulczynski, MD	Elisa Jacobsen Pulczynski, MD Telephone + 45 89 49 79 36	Dept. Haematology R Univerity Hospital Aarhus Tage Hansens Gade 2 DK-8000 Aarhus Telephone +45 89 49 79 36	Denmark
	Georg Thorsell, MD Telephone + 45 9832 1111	Dept. Haematology B University Hospital Aalborg Hobrovej DK-9000 Aalborg Telephone + 45 9832 1111	Denmark
	Ivan Andersen, MD Telephone +45 6541 1158	Dept. Haematology X Odense University Hospital DK- 5100 Odense Telephone +45 6541 1158	Denmark
	Per Boye Hansen	Dept. Haematology L Herlev University Hospital Herlev Ringvej DK-2730 Herlev Telephone +45 4488 3905	Denmark
Outi Kuittinen, MD		Dept. Radiother. and Oncol Oulu University Hospital PL 22 902210YS Telephone 358(0)83153206	Finland
Unn-Merete Fagerli, MD		Kreftavdelingen St. Olavs Hospital N-7006 Norge Telephone: (47) 73867836	Norway
Martin Erlansson, MD		Dept. Oncology Umeå University Hospital S-90185 Umeå	Sweden

Monitoring: The study will be monitored according to GCP. The national coordinating

Investigators are responsible for organizing monitoring in each country.

Time schedule: First patient is expected to be enrolled 2006

Last patient is expected to be enrolled 2009

Follow-up for ten years after the completion of all therapy

Table of Contents

Title. 5

1 Introduction. 5

2 Objectives. 7

3 Endpoints. 7

4 Study design. 8

5 Patient eligibility. 8

5.1 Inclusion Criteria. 8

5.2 Exclusion Criteria. 8

5.3 Withdrawal Criteria. 9

6 Registration. 9

7 Treatment 9

7.1 Drug therapy: Time schedule, administration and dose. 9

7.2 Packaging, labeling and storing. 10

7.3 Drug accountability and compliance check. 11

7.4 Treatment plan. 12

8 Pathology. 14

9 Response criteria. 14

10 Diagnostic and pre-treatment examinations. 16

11 Assessment 17

11.1 Assessment during induction therapy. 17

11.2 Final response assessment 17

11.3 Assessment during and at the completion of maintenance therapy. 18

11.4 Assessment during follow-up. 18

12 Schedule of response evaluation. 19

12.1 Response evaluation during induction treatment 19