NIPH Clinical Trials Search

UMIN ID: C000000317

Registered date:05/02/2006

Phase II clinical trials of mature B-cell neoplasms in children: A Japanese Cooperative Studies

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedmature B-cell non-Hodgkin's lymphoa
Date of first enrollment2005/02/01
Target sample size308
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)All registered patients are stratified into four risk groups(G1:stage I/II and resected tumors;G2:stage I/II and unresected tumors;G3:stage III/stage IV CNS negative; G4:stage IV CNS positive & Burkitt leukemia). Patients in G1 will receive two courses of A. Patients in G2 will receive two courses of A and B. Patients in G3 will receive four courses of A and two courses of B. Patients in G4 will receive two courses of A1, A2 and B. Course A consits of PSL,(HD)MTX,CPA, VCR,THP, and course B consists of Ara-C,MTX,VCR,DEX,VP-16. Cranial radiation is omitted for all patients. Standard therapy durations are four weeks in G1, twelve weeks in G2 and eighteen weeks in G3/G4.


Primary Outcome2 year event-free survival
Secondary Outcome(1) 2 year overall survival (2) incidence of therapy-related severe toxicity

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum18years-old
GenderMale and Female
Include criteria
Exclude criteria1, Down's syndrome(21 trisomy) 2, Previous malignancy of any type 3, Prior stem cell/organ transplantation 4, Congenital immunodeficiency 5, HIV positivity

Related Information


public contact
Name Saito akiko
Address 460-0001,Nagoya, naka-ku,sannomaru 4-1-1 Japan
Telephone 052-951-1111
Affiliation JPLSG data center
scientific contact
Name Masahito Tsurusawa
Address Nagakute-cho, Aichi 480-1195 Japan Japan
Telephone 0561-62-3311
Affiliation Aichi Medcial University Hospital Department of Pediatrics