Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Enrolling

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Dasatinib and blinatumomab

Study type: Observational

Funder types: Other

Identifiers

NCT03318770

LAL2217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Study LAL2217 Informed Consent signature.
• Patients enrolled in the GIMEMA LAL2116 protocol and who have completed the 12 months follow-up

Trial design

60 participants in 1 patient group

All patients

Description:

All eligible patients enrolled in the GIMEMA LAL2116 study who have completed 12 months follow-up will be included in this group.

Treatment:

Drug: Dasatinib and blinatumomab