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.
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.
Study Type
OBSERVATIONAL
Enrollment
60
Patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to the protocol LAL2116
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
Number of patients alive
Time frame: At five years since study entry
Number of therapeutic choices taken after dasatinib and blinatumomab (induction/consolidation) according to individual medical decisions and clinical practice.
Characteristics of these choices
Time frame: At five years from study entry
Number of days in complete molecular remission.
Duration of remission
Time frame: At five years from study entry
Number of patients in disease-free survival
Time frame: At five years from study entry
Number of adverse events
Long-term safety profile
Time frame: At five years from study entry
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