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

Acute Lymphoblastic Leukemia Clinical Trial

— GRAALL2003  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222027
• Other study ID #: 0200701
• Secondary ID: PHRC
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: January 6, 2009
• Start date: November 2003
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 59 Years

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

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

Intervention

Procedure:
• Collection of treatment-stratefying prognostic factors

Locations

Country	Name	City	State
France	Service d'Hématologie Clinique, Hôpital Purpan	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL
Secondary	Hematologic and non hematologic toxicity of induction, consolidation and late intensification.