Phase II trial using imatinib combined with chemotherapy for newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)

UMIN ID: UMIN000001226

Registered date:07/07/2008

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)
• Date of first enrollment: 2008/08/01
• Target sample size: 66
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Induction CPM 1.2 g/m2 (*800 mg/m2) day 1 DNR 60 mg/m2 (*30 mg/m2) day 1-3 VCR 1.3 mg/m2 (max 2 mg)day 1,8,15,22 PSL 60 mg/m2 PO on day 1-21 (*7) tapered Imatinib 600 mg/body/day on day 8-42 MTX 15 mg + Ara-C 40 mg + DEX 4 mg/body IT on day 29 (*optional age 60-64) Consolidation 1 MTX 1 g/m2 24hr-DIV on day 1 Ara-C 2 g/m2 (*1 mg/m2) 4 doses q 12h on day 2,3 mPSL 50 mg/body bid IV on day 1-3 Imatinib 600 mg/body/day on day 4-21 MTX 15mg/body + Ara-C 40mg/body + DEX 4mg/body IT on day 1 Consolidation 2 CPM 1.2 g/m2 on day 1 DNR 60 mg/m2 on day 1 VCR 1.3 mg/m2 (max 2 mg) on day 1 PSL 60 mg/m2 on day 1-7 Imatinib 600 mg/body/day on day 2-21 MTX 15 mg/body + Ara-C 40 mg/body + DEX 4 mg/body IT on day 1 Maintenance Imatinib 600 mg/body/day on day 1-28 VCR 1.3 mg/m2 (max 2 mg) on day 1 PSL 60 mg/m2 on day 1-5

Outcome(s)

• Primary Outcome: Two-year event free survival. Events are defined as any induction failure, relapse or death of any reason.
• Secondary Outcome: 1) Complete remission rate 2) Rate of adverse events 3) Five year overall survival 4) Conversion rate of BCR-ABL product, time to MRD negativity, time to reappearance of MRD and the mutation status of the gene. 5) Efficay and toxicity of transplantation

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: 1) Infectious disease of Grade 4 2) Positive HIVAb or HBsAg 3) Active cancer other than ALL 4) Female patients who are pregnant or breast-feeding 5) Reject by responsible physician

Related Information

• Primary Sponsor: Japan Adult Leukemia Study Group
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare, "Study on establishment of the standard therapy to adult refractory leukemia&quot