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


Phase 2
15 Years
59 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Françoise HUGUET-RIGAL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Toulouse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0200701

NCT ID:

NCT00222027

Start Date:

November 2003

Completion Date:

December 2008

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute lymphoblastic leukemia
  • adult patient
  • chemotherapy
  • stem cell transplantation
  • Young adult patients
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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