GIMEMA LAL 0496: High-Dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.
| Tracking Information | |||||
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| First Received Date ICMJE | February 23, 2007 | ||||
| Last Updated Date | February 23, 2007 | ||||
| Start Date ICMJE | October 1996 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | GIMEMA LAL 0496: High-Dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL. | ||||
| Official Title ICMJE | GIMEMA LAL 0496: High-Dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial. | ||||
| Brief Summary | The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis. |
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| Detailed Description | The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated. This study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Acute Lymphoblastic Leukemia | ||||
| Intervention ICMJE | Drug: High-dose anthracycline | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | May 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00439920 | ||||
| Other Study ID Numbers ICMJE | LAL0496 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Gruppo Italiano Malattie EMatologiche dell'Adulto | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Gruppo Italiano Malattie EMatologiche dell'Adulto | ||||
| Verification Date | September 2000 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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