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

November 11, 2011
May 22, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01475110 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
    Rate of major molecular remission with Nilotinib treatment and the duration of the responses.
Not Provided
Not Provided
 
Observational Study in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia (CML) Treated With Nilotinib: Follow-up of the Italian Patients
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Chronic Myeloid Leukaemia
Drug: Imatinib
Observation of Imatinib resistant patients treated with Nilotinib.
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.

Intervention: Drug: Imatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Paola FAZI, Dr. p.fazi@gimema.it
Contact: Enrico CREA e.crea@gimema.it
Italy
 
NCT01475110
CML0609
No
Gruppo Italiano Malattie EMatologiche dell'Adulto
Gruppo Italiano Malattie EMatologiche dell'Adulto
Not Provided
Principal Investigator: Giuseppe SAGLIO, Pr. Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
Gruppo Italiano Malattie EMatologiche dell'Adulto
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP