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

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ClinicalTrials.gov Identifier: NCT00222027
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 7, 2009
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Procedure: Collection of treatment-stratefying prognostic factors Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GRAALL 2003 Trial (ALL 15-59 Years). Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial
Study Start Date : November 2003
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008





Primary Outcome Measures :
  1. Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL

Secondary Outcome Measures :
  1. Hematologic and non hematologic toxicity of induction, consolidation and late intensification.


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Ages Eligible for Study:   15 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222027


Locations
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France
Service d'Hématologie Clinique, Hôpital Purpan
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Ministry of Health, France
Investigators
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Principal Investigator: Françoise HUGUET-RIGAL, MD University Hospital, Toulouse

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LLAU Marie-Elise, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00222027     History of Changes
Other Study ID Numbers: 0200701
PHRC
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009

Keywords provided by University Hospital, Toulouse:
Acute lymphoblastic leukemia
adult patient
chemotherapy
stem cell transplantation
Young adult patients

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases