CML0609: Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib
Study Details
Study Description
Brief Summary
The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment will include all patients who started Nilotinib between January 2005 and December 2012. Patients will be followed for 4 years since treatment start. After this time, survival data, disease status and treatment will be recorded at 6-months-interval. This study will help the definition of guidelines for a proper management of Nilotinib in any-phase CML patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Follow-up is required until the end of treatment for the purposes of the study for all patients by standard hematologic, cytogenetic and molecular criteria. This study will not contemplate any additional expense beyond what is expected for a regular follow-up, according to the international guidelines for CML.
Sample Size: target accrual was not defined, all eligible patients observed between January 2005 and December 2012 will be included.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Imatinib
Observation of Imatinib resistant patients treated with Nilotinib.
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [At one year from study entry]
Secondary Outcome Measures
- Rate of complete haematologic remission t [At one year from study entry]
Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses.
- Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death [At one year from study entry]
- Event Free Survival (EFS) [At one year from study entry]
- Progression Free Survival (PFS) [At one year from study entry]
- Rate of point mutations before or after Nilotinib treatment [At one year from study entry]
- Rate of major cytogenetic response [At one year from study entry]
Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses.
- Rate of compete cytogenetic response [At one year from study entry]
Rate of complete cytogenetic response with Nilotinib treatment and the duration of the responses.
- Rate of major molecular remission [At one year from study entry]
Rate of major molecular remission with Nilotinib treatment and the duration of the responses.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Patients less than 18 year old.
-
Use of Nilotinib as first line treatment.
-
Patients treated with Nilotinib before 2005.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro Oncologico Basilicata | Rionero in Vulture | Potenza | Italy | |
| 2 | Ospedale | Alessandria | Italy | ||
| 3 | S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | ||
| 4 | S.G. Moscati Hospital | Avellino | Italy | ||
| 5 | Ospedale | Bari | Italy | ||
| 6 | Ospedale | Bologna | Italy | ||
| 7 | Azienda Spedali Civili | Brescia | Italy | 25100 | |
| 8 | Ospedale Ferrarotto | Catania | Italy | ||
| 9 | Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna | Ferrara | Italy | 44100 | |
| 10 | Policlinico di Careggi, Università delgi studi di Firenze | Firenze | Italy | ||
| 11 | Clinica Ematologica - Università degli Studi | Genova | Italy | ||
| 12 | Università degli Studi | Genova | Italy | ||
| 13 | Università di Genova | Genova | Italy | ||
| 14 | ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia | Lecce | Italy | 73100 | |
| 15 | A.O. Universitaria Policlinico Martina di Messina | Messina | Italy | ||
| 16 | U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele | Milano | Italy | 20132 | |
| 17 | Federico II | Napoli | Italy | ||
| 18 | Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10 | Orbassano | Italy | ||
| 19 | Azienda Ospedaliera di Padova | Padova | Italy | 35128 | |
| 20 | Ospedale Cervello | Palermo | Italy | 90146 | |
| 21 | Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone | Palermo | Italy | ||
| 22 | Dipartimento Oncologico - Ospedale S.Maria delle Croci | Ravenna | Italy | ||
| 23 | Ospedale | Reggio Calabria | Italy | ||
| 24 | Ospedale | Rimini | Italy | ||
| 25 | U.O. di Ematologia - Centro Oncologico Basilicata | Rionero in Vulture | Italy | ||
| 26 | Ematologia - Sapienza Università di Roma | Roma | Italy | ||
| 27 | Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | Italy | 00168 | |
| 28 | Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy | ||
| 29 | U.O. Ematologia, Azienda Ospedaliera Universitaria Senese | Siena | Italy | 53100 | |
| 30 | Ospedale | Taranto | Italy | ||
| 31 | SCDO Ematologia 2 AOU S. Giovanni Battista | Torino | Italy | ||
| 32 | Policlinico Universitario - Clinica Ematologia | Udine | Italy | 33100 | |
| 33 | Policlinico G. B. Rossi - Borgo Roma | Verona | Italy | 37134 |
Sponsors and Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
- Principal Investigator: Giuseppe SAGLIO, Pr., Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CML0609