Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute lymphoblastic leukemia, adult patient, chemotherapy, stem cell transplantation, Young adult patients
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* 15-59 years * acute lymphoblastic leukemia newly diagnosed * signed written informed consent
Exclusion criteria
* Lymphoblastic lymphoma * Acute lymphoblastic leukemia 3 * Chronic Myeloid Leukemia acutisation * Sever organ condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematologic and non hematologic toxicity of induction, consolidation and late intensification. | — |
Countries
France