Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib
NCT ID: NCT01475110
Last Updated: 2022-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
19 participants
OBSERVATIONAL
2012-09-13
2016-11-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia
NCT00376467
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
NCT00905593
Intermittent Imatinib Treatment in Chronic Myeloid Leukemia and Philadelphia Chromosome (Ph+CML) Patients Who Achieved a Complete Cytogenetic Response (CCgR) on Standard Imatinib Therapy
NCT00858806
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
NCT00471497
Oblimersen and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
NCT00049192
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Sample Size: target accrual was not defined, all eligible patients observed between January 2005 and December 2012 will be included.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study cohort group
Adult patients with Imatinib resistant (failure + suboptimal) or intolerant chronic myeloid leukaemia in all phases, who started treatment with Nilotinib between January 2005 and December 2012 in Italy.
Adult pts treated with Nilotinib as second line therapy after Dasatinib.
Imatinib
Observation of Imatinib resistant patients treated with Nilotinib.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Imatinib
Observation of Imatinib resistant patients treated with Nilotinib.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult pts treated with Nilotinib as second line therapy after Dasatinib.
Exclusion Criteria
* Use of Nilotinib as first line treatment.
* Patients treated with Nilotinib before 2005.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giuseppe SAGLIO, Pr.
Role: PRINCIPAL_INVESTIGATOR
Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centro Oncologico Basilicata
Rionero in Vulture, Potenza, Italy
Ospedale
Alessandria, , Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
S.G. Moscati Hospital
Avellino, , Italy
Ospedale
Bari, , Italy
Ospedale
Bologna, , Italy
Azienda Spedali Civili
Brescia, , Italy
Ospedale Ferrarotto
Catania, , Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, , Italy
Policlinico di Careggi, Università delgi studi di Firenze
Florence, , Italy
Clinica Ematologica - Università degli Studi
Genova, , Italy
Università degli Studi
Genova, , Italy
Università di Genova
Genova, , Italy
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
Lecce, , Italy
A.O. Universitaria Policlinico Martina di Messina
Messina, , Italy
U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele
Milan, , Italy
Federico II
Napoli, , Italy
Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10
Orbassano, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Ospedale Cervello
Palermo, , Italy
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
Palermo, , Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna, , Italy
Ospedale
Reggio Calabria, , Italy
Ospedale
Rimini, , Italy
U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture, , Italy
Ematologia - Sapienza Università di Roma
Roma, , Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Ospedale
Taranto, , Italy
SCDO Ematologia 2 AOU S. Giovanni Battista
Torino, , Italy
Policlinico Universitario - Clinica Ematologia
Udine, , Italy
Policlinico G. B. Rossi - Borgo Roma
Verona, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
GIMEMA Foundation Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CML0609
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.