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GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.

GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00439920
Enrollment
Unknown
Registered
2007-02-26
Start date
1996-10-31
Completion date
2018-12-31
Last updated
2018-10-23

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

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL

Brief summary

The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.

Detailed description

The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated. This study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation.

Interventions

DRUGHigh-dose anthracycline

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 16-60 * Diagnosed with previously untreated T-ALL and B-ALL

Exclusion criteria

* previously treated ALL patients * L3 B-ALL

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with complete responsePatients are followed-up for response till death

Secondary

MeasureTime frameDescription
Number of patients that reach disease-free-survivalPatients are followed-up for response till death

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026