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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: |
NCT00219765 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients
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Scientific title:
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Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase |
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Date of first enrolment:
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May 2001 |
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Target sample size:
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30 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00219765 |
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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: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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François GUILHOT, 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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Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- CML Ph+ (assessed by cytogenetic or FISH)
- Acute phase with = 20% bone marrow blasts (M0 to M6 , excluding M3)
- Age = 18 year at inclusion
- PS grade 0 to 2 (ECOG)
- Adequate and organ function, defined as the following: total bilirubin <1.5x uln,
sgpt <3x uln, creatinine <1.5x uln.
- Informed consent signed up
Exclusion Criteria:
- active malignancy other than CML or non-melanoma cancer of the skin
- current treatment with another investigational agent
- patients with grade 3/4 cardiac disease or any other serious concurrent medical
condition.
- patients who are pregnant or nursing. All patients of childbearing potential must
practice effective methods of contraception while on study.
- patients with mental illness or other condition precluding their ability to give
informed consent or to comply with study requirements patients with performans status
3-4
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Myeloid Leukemia
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Intervention(s)
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Drug: Cytarabine
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Drug: Daunorubicine
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Drug: Imatinib mesylate 600 mg
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Primary Outcome(s)
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To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine
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Secondary Outcome(s)
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- To evaluate duration of responses and failure to respond
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- To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
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Secondary ID(s)
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010495
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CSTI571AFR01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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