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

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Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL

Secondary Outcome

 Hematologic and non hematologic toxicity of induction, consolidation and late intensification.

Condition

Acute Lymphoblastic Leukemia

Intervention

Collection of treatment-stratefying prognostic factors


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

300

Start Date

November 2003

Completion Date

December 2008

Primary Completion Date

October 2008

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
      

Gender

All

Ages

15 Years - 59 Years

Accepts Healthy Volunteers

No

Contacts

Françoise HUGUET-RIGAL, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00222027

Organization ID

0200701

Secondary IDs

PHRC


Study Sponsor

University Hospital, Toulouse

Collaborators

 Ministry of Health, France

Study Sponsor

Françoise HUGUET-RIGAL, MD, Principal Investigator, University Hospital, Toulouse


Verification Date

January 2009