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

UMIN ID: C000000317

Registered date:05/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: mature B-cell non-Hodgkin's lymphoa
• Date of first enrollment: 2005/02/01
• Target sample size: 308
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude criteria: 1, 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

• Primary Sponsor: Japanese Pediatric Leukemia/Lymphoma Studu Group(JPLSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare