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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00130195 |
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Date of registration:
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12/08/2005 |
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Primary sponsor: |
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Public title:
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Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)
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Scientific title:
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Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00130195 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Fumihiko Hayakawa, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nagoya University Graduate School of Medicine |
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Name:
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Tomoki Naoe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nagoya University Graduate School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previously untreated BCR-ABL-positive ALL
- Age between 15 and 64 years
- Performance status between 0 and 3 (ECOG criteria)
- Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum
creatinine level < 2.0 mg/dL), and heart (left ventricular ejection fraction greater
than 50% and no severe abnormalities detected on electrocardiograms and
echocardiographs)
- Written informed consent to participate in the trial
Exclusion Criteria:
- Uncontrolled active infection
- Another severe and/or life-threatening disease
- Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
- Another primary malignancy which is clinically active and/or requires medical
interventions
- Pregnant and/or lactating women
- Past history of renal failure
Age minimum:
15 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Lymphoblastic Leukemia
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Intervention(s)
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Drug: cyclophosphamide
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Drug: cytarabine
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Drug: daunorubicin
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Drug: dexamethasone
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Drug: imatinib
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Drug: methotrexate
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Drug: prednisolone
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Drug: vincristine
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Primary Outcome(s)
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The rate of complete remission
[Time Frame: 63 days]
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Secondary Outcome(s)
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Overall survival
[Time Frame: 1 year]
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The duration of remission
[Time Frame: 1 year]
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Toxicity caused by combination of imatinib and chemotherapy
[Time Frame: 2 years]
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Secondary ID(s)
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JALSG Ph+ALL202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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