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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03318770

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Dasatinib and blinatumomab

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Ancillary Observational Study of Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
All patients All eligible patients enrolled in the GIMEMA LAL2116 study who have completed 12 months follow-up will be included in this group.	Drug: Dasatinib and blinatumomab Patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to the protocol LAL2116

Arm

Intervention/Treatment

All patients

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

Drug: Dasatinib and blinatumomab

Patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to the protocol LAL2116

Outcome Measures

Primary Outcome Measures

Number of patients alive [At five years since study entry]

Secondary Outcome Measures

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