Treatment for CD20-positive central nervus system lymphoma with autologous serum and rituximab into the ventricle

UMIN ID: UMIN000000968

Registered date:15/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: CD20-positive primary central nervus system lymphoma, or relapsed CD20-positive non-Hodgkin lymphoma in CNS alone
• Date of first enrollment: 2007/01/01
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Day 1: Intraventricle injection of 10 mg (1 ml) of rituximab and 8 ml of autologous serum via Ommaya reservoir. Day 3: Intraventricle injection of 40 mg (4 ml) of rituximab and 8 ml of autologous serum via Ommaya reservoir. Day 6: Intraventricle injection of 50 mg (5 ml) of rituximab and 8 ml of autologous serum via Ommaya reservoir. Day 7-14: Ovservation. Above day 1 to day 14 is defined as a course. The therapy can be repeated by two or more courses if the disease is improved or stable.

Outcome(s)

• Primary Outcome: Response

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Poor general status (ECOG Performance status 3 or 4). Inablity in understanding of the therapy even due to the primary disease. Lesions outside of central nervas system which are uncontroled or less than three months from shrinking.

Related Information

• Primary Sponsor: Division of Hematology, University of Tsukuba
• Source(s) of Monetary Support: Tsukuba Critical Path Research and Education Integrated Leading Center