Observational Study in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia (CML) Treated With Nilotinib: Follow-up of the Italian Patients (CML0609)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01475110
First received: November 11, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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 Intervention
Chronic Myeloid Leukaemia
Drug: Imatinib

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia (CML) Treated With Nilotinib: Follow-up of the Italian Patients. GIMEMA Study CML0609

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complete haematologic remission t [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
    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 [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
  • Event Free Survival (EFS) [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
  • Rate of point mutations before or after Nilotinib treatment [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
  • Rate of major cytogenetic response [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
    Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses.

  • Rate of compete cytogenetic response [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
    Rate of complete cytogenetic response with Nilotinib treatment and the duration of the responses.

  • Rate of major molecular remission [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
    Rate of major molecular remission with Nilotinib treatment and the duration of the responses.


Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollement will include all patients who started Nilotinib between January 2005 and December 2012.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475110

Contacts
Contact: Paola FAZI, Dr. p.fazi@gimema.it
Contact: Enrico CREA e.crea@gimema.it

Locations
Italy
Centro Oncologico Basilicata Recruiting
Rionero in Vulture, Potenza, Italy
Contact: Pellegrino Musto, MD, PhD         
Principal Investigator: Pellegrino MUSTO, Pr.         
Ospedale Recruiting
Alessandria, Italy
Contact: Pini         
Principal Investigator: Pini         
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, Italy
Contact: Massimo Pini, Dr.         
Principal Investigator: Massimo Pini, Dr.         
S.G. Moscati Hospital Recruiting
Avellino, Italy
Contact: Fausto Palmieri, Dr.         
Principal Investigator: Fausto Palmieri, Dr.         
Ospedale Recruiting
Bari, Italy
Contact: Specchia         
Principal Investigator: Specchia         
Ospedale Recruiting
Bologna, Italy
Contact: Cagnetti         
Principal Investigator: Cagnetti         
Azienda Spedali Civili Recruiting
Brescia, Italy, 25100
Contact: Domenico RUSSO         
Ospedale Ferrarotto Recruiting
Catania, Italy
Contact: Francesco Di Raimondo, Pr.         
Principal Investigator: Francesco Di Raimondo, Pr.         
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna Recruiting
Ferrara, Italy, 44100
Contact: Antonio CUNEO, Pr.         
Principal Investigator: Antonio CUNEO, Pr.         
Sub-Investigator: Gian Matteo Rigolin, Dr.         
Policlinico di Careggi, Università delgi studi di Firenze Recruiting
Firenze, Italy
Contact: Alberto BOSI         
Principal Investigator: Alberto BOSI, Dr.         
Sub-Investigator: Giacomo GIANFALDONI, Dr.         
Clinica Ematologica - Università degli Studi Recruiting
Genova, Italy
Contact: Angelo Michele CARELLA, Pr.         
Principal Investigator: Angelo Michele CARELLA, Pr.         
Università di Genova Recruiting
Genova, Italy
Contact: Pierri         
Principal Investigator: Pierri         
Università degli Studi Recruiting
Genova, Italy
Contact: Pierri         
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia Recruiting
Lecce, Italy, 73100
Contact: Nicola DI RENZO         
Principal Investigator: Nicola DI RENZO, Dr.         
A.O. Universitaria Policlinico Martina di Messina Recruiting
Messina, Italy
Contact: Caterina MUSSOLINO, Pr.         
Principal Investigator: Caterina MUSSOLINO, Pr.         
U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele Recruiting
Milano, Italy, 20132
Contact: Fabio CICERI       ciceri.fabio@hsr.it   
Principal Investigator: Fabio Ciceri, MD         
Federico II Recruiting
Napoli, Italy
Contact: Pane         
Principal Investigator: Pane         
Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10 Recruiting
Orbassano, Italy
Contact: Giuseppe Saglio, Pr         
Principal Investigator: Saglio         
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact: Gianpietro C. Semenzato, MD    39-049-821-2298    g.semenzato@unipd.it   
Ospedale Cervello Recruiting
Palermo, Italy, 90146
Contact: Turri         
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone Recruiting
Palermo, Italy
Contact: Clementina Caracciolo, Dr.         
Principal Investigator: Clementina Caracciolo, Dr.         
Principal Investigator: Rosaria Di Maggio, Dr.         
Dipartimento Oncologico - Ospedale S.Maria delle Croci Recruiting
Ravenna, Italy
Contact: Maria Salvucci, Dr.         
Principal Investigator: Maria Salvuci, Dr.         
Ospedale Recruiting
Reggio Calabria, Italy
Contact: Martino         
Principal Investigator: Martino         
Ospedale Recruiting
Rimini, Italy
Contact: Tosi         
Principal Investigator: Tosi         
U.O. di Ematologia - Centro Oncologico Basilicata Recruiting
Rionero in Vulture, Italy
Contact: Pellegrino Musto       p.musto@tin.it   
Ematologia - Sapienza Università di Roma Recruiting
Roma, Italy
Principal Investigator: Giuliana Alimena, MD         
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore Recruiting
Rome, Italy, 00168
Contact: Sica         
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
S. G. Rotondo, Italy
Contact: Nicola Cascavila, Pr.       n.cascavilla@operapadrepio.it   
Principal Investigator: Nicola Cascavilla, Pr.         
Principal Investigator: Lorella Melillo, Dr.         
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Monica BOCCHIA, Dr.         
Principal Investigator: Monica BOCCHIA, Dr.         
Ospedale Recruiting
Taranto, Italy
Contact: Iannitto         
Principal Investigator: Iannito         
SCDO Ematologia 2 AOU S. Giovanni Battista Recruiting
Torino, Italy
Contact: Patrizia Pregno, Dr.         
Principal Investigator: Patrizia Pregno, Dr.         
Sub-Investigator: Paola Riccomagno, Dr.         
Policlinico Universitario - Clinica Ematologia Recruiting
Udine, Italy, 33100
Contact: Mario Tiribelli, Dr.         
Principal Investigator: Mario Tiribelli, Dr.         
Policlinico G. B. Rossi - Borgo Roma Recruiting
Verona, Italy, 37134
Contact: Giovanni Pizzolo, MD       giovanni.pizzolo@univr.it   
Principal Investigator: Giovanni PIZZOLO, Pr.         
Sub-Investigator: Dino DE VENERI, Dr.         
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
  More Information

Additional Information:
No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01475110     History of Changes
Other Study ID Numbers: CML0609
Study First Received: November 11, 2011
Last Updated: May 22, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Imatinib
Chronic Myeloid Leukaemia
Nilotinib
Adult patients
Imatinib resistant

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014