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

NCT ID: NCT00222027

Last Updated: 2009-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2008-12-31

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.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Collection of treatment-stratefying prognostic factors

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Toulouse

Principal Investigators

Françoise HUGUET-RIGAL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Service d'Hématologie Clinique, Hôpital Purpan

Toulouse, , France

Countries

France

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Other Identifiers

PHRC

Identifier Type: -

Identifier Source: secondary_id

0200701

Identifier Type: -

Identifier Source: org_study_id