Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- Registration Number
- NCT03318770
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Study LAL2217 Informed Consent signature.
- Patients enrolled in the GIMEMA LAL2116 protocol and who have completed the 12 months follow-up
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 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
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
Trial Locations
- Locations (17)
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
🇮🇹Bergamo, Italy
Aou Careggi - Firenze - Sod Ematologia
🇮🇹Firenze, Italy
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
🇮🇹Orbassano, Italy
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
🇮🇹Novara, Italy
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
🇮🇹Pagà ni, Italy
Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma
🇮🇹Rome, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
🇮🇹Roma, Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
🇮🇹Verona, Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
🇮🇹Bari, Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
🇮🇹Catania, Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
🇮🇹Brescia, Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
🇮🇹Mestre, Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
🇮🇹Lecce, Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
🇮🇹Milano, Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
🇮🇹Roma, Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
🇮🇹Perugia, Italy
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
🇮🇹Parma, Italy