Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial — GRAALL2003  

Acute Lymphoblastic Leukemia Clinical Trial

Official title: GRAALL 2003 Trial (ALL 15-59 Years). Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial

Status Completed

Clinical Trial Summary

Several prognostic predictors, including baseline ALL features and response to initial therapy, have been described in adult ALL raising the issue of whether these predictors might be redundant and which must be considered for treatment stratification. In the GRAALL-2003 prospective Phase 2 study, we aim to hierarchize the following high-risk factors in Ph-negative ALL patients.

Clinical Trial Description

1) baseline (BL) : WBC30G/L in B-lineage, CNS involvement, MLL-AF4 and E2A-PBX fusions, haploidy/near-triploidy; 2) early response (ER) : corticoresistance after prophase (CsR), chemoresistance at Day 8 (ChR); all CsR and/or ChR patients are planned to receive higher doses of cyclophosphamide (HyperC) at Day 15 of induction; 3) induction response (IR) : no CR or Ig-TCR minimal residual disease (MRD) 10-2 after standard or HyperC induction. Allogeneic stem cell transplantation is proposed to patients with a donor and at least one BL, ER, or IR factor. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT00222027
• Study type: Interventional
• Source: University Hospital, Toulouse
• Status: Completed
• Phase: Phase 2
• Start date: November 2003
• Completion date: December 2008