Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
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
1 other identifier
observational
60
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2019
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedStudy Start
First participant enrolled
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedOctober 12, 2022
October 1, 2022
5 years
October 19, 2017
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients alive
At five years since study entry
Secondary Outcomes (4)
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
Number of days in complete molecular remission.
At five years from study entry
Number of patients in disease-free survival
At five years from study entry
Number of adverse events
At five years from study entry
Study Arms (1)
All patients
All eligible patients enrolled in the GIMEMA LAL2116 study who have completed 12 months follow-up will be included in this group.
Interventions
Patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to the protocol LAL2116
Eligibility Criteria
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).
You may qualify if:
- Study LAL2217 Informed Consent signature.
- Patients enrolled in the GIMEMA LAL2116 protocol and who have completed the 12 months follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Florence, 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
Milan, Italy
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
Novara, Italy
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano, Italy
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagàni, Italy
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma, Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia, Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
Roma, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma, Italy
Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma
Rome, Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Roberto Foà, Prof.
Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2017
First Posted
October 24, 2017
Study Start
May 10, 2019
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
October 12, 2022
Record last verified: 2022-10