NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001226

Registered date:07/07/2008

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNewly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)
Date of first enrollment2008/08/01
Target sample size66
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeTwo-year event free survival. Events are defined as any induction failure, relapse or death of any reason.
Secondary Outcome1) 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 minimum15years-old
Age maximum64years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Hideki Akiyama
Address 3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-3823-2101
E-mail hakiyama@cick.jp
Affiliation Tokyo Metropolitan Komagome Hospital Hematology Division
scientific contact
Name Hideki Akiyama
Address 3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan Japan
Telephone 03-3823-2101
E-mail
Affiliation Tokyo Metropolitan Komagome Hospital Hematology Division