GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00439920|
Recruitment Status : Active, not recruiting
First Posted : February 26, 2007
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: High-dose anthracycline||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.|
|Actual Study Start Date :||October 1996|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
|Experimental: High-dose anthracycline||Drug: High-dose anthracycline|
- Number of patients with complete responsePatients are followed-up for response till death
- Number of patients that reach disease-free-survivalPatients are followed-up for response till death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439920
|Principal Investigator:||Franco Mandelli, Prof.||Università degli Studi di Roma "La Sapienza"|