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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00222027
Acronym
GRAALL2003
Enrollment
300
Registered
2005-09-22
Start date
2003-11-30
Completion date
2008-12-31
Last updated
2009-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute lymphoblastic leukemia, adult patient, chemotherapy, stem cell transplantation, Young adult patients

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.

Interventions

PROCEDURECollection of treatment-stratefying prognostic factors

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 59 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026