Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute Lymphoblastic Leukemia, adult, dasatinib, blinatumomab, LAL2116
Brief summary
The primary objective of the present study is to evaluate the long-term observation, in terms of overall survival, of adult Ph+ ALL patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to GIMEMA protocol LAL2116.
Detailed description
Since the treatment after dasatinib and blinatumomab is not uniform and highly dependent on medical decisions, the primary aim of this ancillary trial is to evaluate the long-term follow-up of patients enrolled in the GIMEMA 2116, in terms of overall survival (OS). Furthermore, the secondary objectives are the collection of data and survival outcomes relative to the therapeutic choices carried out after dasatinib and blinatumomab (i.e. allo-SCT, autologous transplant, TKI maintenance, etc), duration of CMR, DFS, long-term safety profile. A correlation of survival outcomes (OS, DFS, etc) with the clinical and biological findings will be carried out with data collected at diagnosis and during the follow-up within the LAL2116 trial.
Interventions
DRUGDasatinib and blinatumomab
Patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to the protocol LAL2116
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Study LAL2217 Informed Consent signature. * Patients enrolled in the GIMEMA LAL2116 protocol and who have completed the 12 months follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients alive | At five years since study entry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of therapeutic choices taken after dasatinib and blinatumomab (induction/consolidation) according to individual medical decisions and clinical practice. | At five years from study entry | Characteristics of these choices |
| Number of days in complete molecular remission. | At five years from study entry | Duration of remission |
| Number of patients in disease-free survival | At five years from study entry | — |
| Number of adverse events | At five years from study entry | Long-term safety profile |
Countries
Italy
Contacts
Primary ContactPaola Fazi
Backup ContactEnrico Crea
Outcome results
None listed