Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients with BCR-ABL-Negative Acute Lymphoblastic Leukemia (JALSG ALL202-U)

UMIN ID: C000000064

Registered date:17/08/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Acute lymphoblastic leukemia
• Date of first enrollment: 2002/09/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Induction therapy (Week 1-5): MTX, PSL, DEX, VCR, THP-ADR, CPM, L-ASP, Ara-C, HDC. Consolidation therapy (Week 6-9): CPM, THP-ADR, Ara-C, 6MP, MTX, HDC. Sanctuary therapy (Week 10-11): MTX, Ara-C, HDC. Reinduction therapy (Week 12-15): VCR, THP-ADR, CPM, L-ASP, PSL, MTX, Ara-C, HDC. Reconsolidation therapy (Week 16-19): CPM, THP-ADR, Ara-C, 6MP, MTX, HDC. Maintenance therapy (Week 20-25): MTX, 6MP, CPM, THP-ADR, Ara-C, 6MP, HDC. Maintenance therapy (Week 26-29, 46-49, 66-69, 86-89): VCR, CPM , L-ASP, PSL. Maintenance therapy (Week 30-35, 40-45, 50-55, 60-65, 70-75, 80-85, 90-95): MTX, 6MP, Ara-C, HC. Maintenance therapy (Week 36-39, 56-59, 76-79, 96-98): VCR, THP-ADR, L-ASP, PSL.

Outcome(s)

• Primary Outcome: Disease-free survival at 3 years
• Secondary Outcome: Toxicity, the rate of complete remission

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 25years-old
• Gender: Male and Female
• Exclude criteria: (1) Uncontrolled active infection (2) Another severe and/or life-threatening disease (3) Positive for HIV antibody and/or HBs antigen tests (4) Another primary malignancy which is clinically active and/or requires medical interventions (5) Pregnant and/or lactating woman (6) Past history of renal failure

Related Information

• Primary Sponsor: Japan Adult Leukemia Study Group
• Source(s) of Monetary Support: Japan: Ministry of Health, Labor and Welfare
• Secondary ID(s): NCT00131053