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

Toulouse University Hospital

Status and phase: Completed; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Procedure: Collection of treatment-stratefying prognostic factors

Study type: Interventional

Funder types: Other

Identifiers

NCT00222027

PHRC

0200701

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 15 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)