NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000968

Registered date:15/01/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedCD20-positive primary central nervus system lymphoma, or relapsed CD20-positive non-Hodgkin lymphoma in CNS alone
Date of first enrollment2007/01/01
Target sample size5
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeResponse
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPoor 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

Contact

public contact
Name
Address Japan
Telephone
E-mail yokoshi@md.tsukuba.ac.jp
Affiliation University of Tsukuba Division of Hematology
scientific contact
Name Yasushi Okoshi
Address Tennoudai 1-1-1, Tsukuba, Ibaraki Japan
Telephone
E-mail
Affiliation University of Tsukuba Division of Hematology