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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Collection of treatment-stratefying prognostic factors
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Acute lymphoblastic leukemia, adult patient, chemotherapy, stem cell transplantation, Young adult patients

Eligibility Criteria

15 Years - 59 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Service d'Hématologie Clinique, Hôpital Purpan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
January 6, 2009
Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00222027
Brief Title
Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial
Acronym
GRAALL2003
Official Title
GRAALL 2003 Trial (ALL 15-59 Years). Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Acute lymphoblastic leukemia, adult patient, chemotherapy, stem cell transplantation, Young adult patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Collection of treatment-stratefying prognostic factors
Primary Outcome Measure Information:
Title
Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL
Secondary Outcome Measure Information:
Title
Hematologic and non hematologic toxicity of induction, consolidation and late intensification.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise HUGUET-RIGAL, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hématologie Clinique, Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31537687
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
25675863
Citation
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Results Reference
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PubMed Identifier
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Citation
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Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial

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