NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000153

Registered date:10/09/2005

Study of imatinib monotherapy and combination of imatinib with IFN or cytarabine ocfosfate for chronic-phase CML (JALSG CML202 Study)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPreviously untreated chronic-phase chronic myelogenous leukemia
Date of first enrollment2002/04/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Imatinib Imatinib+Interferon-alpha Imatinib+Cytarabine ocfosfate

Outcome(s)

Primary Outcome1) Imatinib monotherapy: overall survival 2) Combination therapy: cytogenetic response at 9 months
Secondary Outcome1) Imatinib monotherapy: toxicity, hematologic response at 6 months, cytogenetic response at 9 months, progression free survival, time to treatment failure 2) Combination therapy: toxicity, hematologic response, cytogenetic response, overall survival, progression free survival, time to treatment failure

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1. Chronic phase CML (Ph+ or BCR-ABL+) previously untreated with IFN 2. Age: 15=< 3. PS 0-3 (ECOG) 4. No severe organ dysfunction 5. Written informed consent
Exclude criteria1. Other active neoplasms 2. Severe comorbidity 3. Hypersensitivity to imatinib 4. Previously treated with IFN 5. Psychological disorders 6. Pregnant and/or lactating woman 7. CML in accelerated phase or blast crisis

Related Information

Contact

public contact
Name Kazunori Ohnishi
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan Japan
Telephone 053-433-4993
E-mail jalsgsc@hama-med.ac.jp
Affiliation JALSG CML202 Study Office Hamamatsu University School of Medicine, Division of Clinical Oncology
scientific contact
Name Kazunori Ohnishi
Address 1-20-1, Handayama, Higashi-ku,Hamamatsu, 431-3192, Japan Japan
Telephone 053-433-4993
E-mail kohnishi@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine Division of Clinical Oncology