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

Recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Dasatinib and blinatumomab

• Registration Number: NCT03318770
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-24
• Study Start: 2019-05-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Dasatinib and blinatumomab	All eligible patients enrolled in the GIMEMA LAL2116 study who have completed 12 months follow-up will be included in this group.

Primary Outcome Measures

Name	Time	Method
Number of patients alive	At five years since study entry

Secondary Outcome Measures

Name	Time	Method
Number of days in complete molecular remission.	At five years from study entry	Duration of remission
Number of adverse events	At five years from study entry	Long-term safety profile
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 patients in disease-free survival	At five years from study entry

Trial Locations

Locations (17)

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto; 🇮🇹 Bari, Italy

Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia; 🇮🇹 Bergamo, Italy

Asst Degli Spedali Civili Di Brescia - Uo Ematologia; 🇮🇹 Brescia, Italy

Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania; 🇮🇹 Catania, Italy

Aou Careggi - Firenze - Sod Ematologia; 🇮🇹 Firenze, Italy

Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia; 🇮🇹 Lecce, Italy

Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia; 🇮🇹 Mestre, Italy

Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora; 🇮🇹 Milano, Italy

Aou Maggiore Della Carita' Di Novara - Scdu Ematologia; 🇮🇹 Novara, Italy

Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia; 🇮🇹 Orbassano, Italy

Scroll for more (7 remaining)