Clinical Trial: Multicenter Trial Treatment of Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia of Young Adults
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).
Brief Summary: The purpose of this study is to prospectively validate the new risk model, based on minimal residual disease (MRD) response level and oncogenetic status by comparing historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).
Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Disease free survival (DFS) [ Time Frame: 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Cumulative incidence of relapse (CIR) [ Time Frame: 4 years ]
- non relapse mortality (NMR) [ Time Frame: 4 years ]
- Overall survival [ Time Frame: 4 years ]
- Cumulative incidence of relapse (CIR) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
- overall survival after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
- Non relapse mortality (NRM) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
- Disease free survival (DFS) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
- Minimal residual disease (MRD) [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: November 25, 2015
Date Started: February 2016
Date Completion: December 2025
Last Updated: November 18, 2016
Last Verified: November 2016