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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03318770
Study type Observational
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone +39 06 70390514
Email p.fazi@gimema.it
Status Recruiting
Phase
Start date May 10, 2019
Completion date May 2024

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