This study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. This will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients.
Treatment: 1. Frail patients: * Pretreatment with PDN * Induction with Vinblastine and PDN * Maintenance with MTX, 6-MP, VBL and PDN 2. Fit patients: * Pretreatment with PDN * Induction with VCR, DNR and PDN * Consolidation with MTX, ARA-C and G-CSF * Autologous transplantation * Maintenance with MTX, 6-MP, VCR, and PDN 3. Intermediate patients: * Pretreatment with PDN * Induction with VCR, DNR and PDN * Consolidation with MTX, ARA-C and G-CSF * A second cycle of consolidation therapy * Maintenance with MTX, 6-MP, VCR, and PDN
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Geriatric assessment is performed before the induction phase starts.
Stem cells autotransplantation is performed after consolidation treatment
Overall survival in Ph negative ALL patients stratified according to a geriatric assessment
Time frame: at 6 months from diagnosis for the Frail group of pts and at 2 years from diagnosis for the Fit and Intermediate group of patients
Complete Response rate
Time frame: After induction therapy
Stem cell autotransplant feasibility
Time frame: At 6 months from diagnosis
Incidence of adult ALL
Time frame: At diagnosis
Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60
Time frame: At diagnosis and during follow-up
Disease free survival
Time frame: During follow-up
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Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
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Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
Genova, Italy
...and 22 more locations