Phase 2 study of induction and early consolidation therapy for acute lymphoblastic leukemia in children (TCCSG ALL L04-16).

UMIN ID: UMIN000001413

Registered date:05/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute Lymphoblastic Leukemia
• Date of first enrollment: 2004/12/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): For standard and intermediate risk patients; Induction therapy-A (Week 1-6): PSL, VCR, THP-ADR, L-ASP, MTX, Ara-C, HDC. Consolidation therapy-A for standard and intermediate risk patients (Week 8-10): 6MP, Ara-C, CPM, MTX, HDC. For high risk patients; Induction therapy-B (Week 1-6): PSL, VCR, THP-ADR,DNR, CPA, L-ASP, MTX, Ara-C, HDC. Early Consolidation therapy-B (Week 8): DEX, MTX, CPA, Ara-C, L-ASP, HDC.

Outcome(s)

• Primary Outcome: The rate of complete remission at the completion of early consolidation.
• Secondary Outcome: 1.The complete remission induction rate 2.The frequency of therapy toxicity

Key inclusion & exclusion criteria

• Age minimum: 1years-old
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude criteria: (1)Symptomatic intracranial hemorrhage (2) Uncontroled infection, (3) Double cancer, Secondary leukemia, (4) Down syndrome, (5) Pregnant, lactating woman, (6) Inadequate functioning of the liver (ALT>200 and serum total bilirubin level > 1.5 mg/dL), kidneys (serum creatinine level >= 1.5 mg/dL), (7) cardiac dysfunction, pulmonary dysfunction

Related Information

• Primary Sponsor: Tokyo Children's Cancer Study Group
• Source(s) of Monetary Support: 1.Ministry of Health, Labor and Welfare, "Study on establishment of the multicenter clinical study for standard therapy to pediatric sarcoma" 2.Children's Cancer Association of Japan