Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults (JALSG ALL202-O)

UMIN ID: C000000063

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: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Induction therapy: CPM, DNR, VCR, PSL, L-ASP. Consolidation therapy 1: Ara-C, ETP, DEX, MTX. Consolidation therapy 2: MTX, VCR, 6MP, DEX. * MTX 3000 mg/sqm, 24h-div, day1,15. Consolidation therapy 3: VCR, ADR, DEX, CPM, 6MP, Ara-C, MTX, DEX. Consolidation therapy 4: Ara-C, ETP, DEX, MTX. Consolidation therapy 5: MTX, VCR, 6MP, DEX. * MTX 3000 mg/sqm, 24h-div, day1,15. Maintenance therapy VCR, PSL, MTX, 6MP.
Induction therapy: CPM, DNR, VCR, PSL, L-ASP. Consolidation therapy 1: Ara-C, ETP, DEX, MTX. Consolidation therapy 2: MTX, VCR, 6MP, DEX. * MTX 500 mg/sqm, 24h-div, day1,15. Consolidation therapy 3: VCR, ADR, DEX, CPM, 6MP, Ara-C, MTX, DEX. Consolidation therapy 4: Ara-C, ETP, DEX, MTX. Consolidation therapy 5: MTX, VCR, 6MP, DEX. * MTX 500 mg/sqm, 24h-div, day1,15. Maintenance therapy VCR, PSL, MTX, 6MP.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 25years-old
• Age maximum: 65years-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): NCT00131027