GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.
|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
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"|