Clinical trial NCT00222027: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute lymphoblastic leukemia
adult patient
chemotherapy
stem cell transplantation
Young adult patients
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL
Secondary outcomes:
measure: Hematologic and non hematologic toxicity of induction, consolidation and late intensification.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service d'Hématologie Clinique, Hôpital Purpan
Study officials:
affiliation: University Hospital, Toulouse
name: Françoise HUGUET-RIGAL, MD
role: PRINCIPAL_INVESTIGATOR
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