Leukemia, Lymphoblastic, Acute
Conditions
Keywords
geriatric assessment adapted therapy, Leukemia, Lymphoblastic, Acute, Older patients, > 60 years old, Ph negative
Brief summary
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.
Detailed description
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
Interventions
PROCEDUREGeriatric assessment adapted therapy
Geriatric assessment is performed before the induction phase starts.
PROCEDUREStem cells autotransplantation
Stem cells autotransplantation is performed after consolidation treatment
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 60 years old * Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and all immunophenotypes except SmIg+ B-ALL) * Signed informed consent
Exclusion criteria
* Age \<= 60 years old * Ph+ ALL * Refuse to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival in Ph negative ALL patients stratified according to a geriatric assessment | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response rate | After induction therapy |
| Stem cell autotransplant feasibility | At 6 months from diagnosis |
| Incidence of adult ALL | At diagnosis |
| Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60 | At diagnosis and during follow-up |
| Disease free survival | During follow-up |
Countries
Italy
Outcome results
None listed