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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukaemia

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Overall Survival

Outcome Time Frame:

At one year from study entry

Safety Issue:

No

Principal Investigator

Giuseppe SAGLIO, Pr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano

Authority:

Italy: Ethics Committee

Study ID:

CML0609

NCT ID:

NCT01475110

Start Date:

February 2012

Completion Date:

December 2012

Related Keywords:

  • Chronic Myeloid Leukaemia
  • Imatinib
  • Chronic Myeloid Leukaemia
  • Nilotinib
  • Adult patients
  • Imatinib resistant
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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