Status:

COMPLETED

Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib

Lead Sponsor:

Gruppo Italiano Malattie EMatologiche dell'Adulto

Conditions:

Chronic Myeloid Leukaemia

Eligibility:

All Genders

18+ years

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 a...

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 additio...

Eligibility Criteria

Inclusion

  • 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

  • Patients less than 18 year old.
  • Use of Nilotinib as first line treatment.
  • Patients treated with Nilotinib before 2005.

Key Trial Info

Start Date :

September 13 2012

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 24 2016

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT01475110

Start Date

September 13 2012

End Date

November 24 2016

Last Update

October 25 2022

Active Locations (33)

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Page 1 of 9 (33 locations)

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