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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | All eligible patients enrolled in the GIMEMA LAL2116 study who have completed 12 months follow-up will be included in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib and blinatumomab | Drug | Patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to the protocol LAL2116 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients alive | At five years since study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Number of therapeutic choices taken after dasatinib and blinatumomab (induction/consolidation) according to individual medical decisions and clinical practice. | Characteristics of these choices | At five years from study entry |
| Number of days in complete molecular remission. |
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Inclusion Criteria:
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All eligible patients enrolled in the LAL2116 and who have completed the 12 months follow-up will be included in this study (a maximum of 60 patients).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola Fazi | Contact | +39 06 70390514 | p.fazi@gimema.it | |
| Enrico Crea | Contact | +39 06 70390514 | e.crea@gimema.it |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Foà, Prof. | Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto | Recruiting | Bari | Italy |
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Duration of remission |
| At five years from study entry |
| Number of patients in disease-free survival | At five years from study entry |
| Number of adverse events | Long-term safety profile | At five years from study entry |
| Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia | Recruiting | Bergamo | Italy |
|
| Asst Degli Spedali Civili Di Brescia - Uo Ematologia | Recruiting | Brescia | Italy |
|
| Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania | Recruiting | Catania | Italy |
|
| Aou Careggi - Firenze - Sod Ematologia | Recruiting | Florence | Italy |
|
| Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia | Recruiting | Lecce | Italy |
|
| Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia | Recruiting | Mestre | Italy |
|
| Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora | Recruiting | Milan | Italy |
|
| Aou Maggiore Della Carita' Di Novara - Scdu Ematologia | Recruiting | Novara | Italy |
|
| Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia | Recruiting | Orbassano | Italy |
|
| Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia | Recruiting | Pagàni | Italy |
|
| Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo | Recruiting | Parma | Italy |
|
| Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo | Recruiting | Perugia | Italy |
|
| Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali | Recruiting | Roma | Italy |
|
| Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia | Recruiting | Roma | Italy |
|
| Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma | Not yet recruiting | Rome | Italy |
|
| Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia | Recruiting | Verona | Italy |
|
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| C510808 | blinatumomab |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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