Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT00222027
- Lead Sponsor
- University Hospital, Toulouse
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 15-59 years
- acute lymphoblastic leukemia newly diagnosed
- signed written informed consent
- Lymphoblastic lymphoma
- Acute lymphoblastic leukemia 3
- Chronic Myeloid Leukemia acutisation
- Sever organ condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL
- Secondary Outcome Measures
Name Time Method Hematologic and non hematologic toxicity of induction, consolidation and late intensification.
Trial Locations
- Locations (1)
Service d'Hématologie Clinique, Hôpital Purpan
🇫🇷Toulouse, France