Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib (CML0609)

October 24, 2022 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
      • Alessandria, Italy
        • Ospedale
      • Avellino, Italy
        • S.G. Moscati Hospital
      • Bari, Italy
        • Ospedale
      • Bologna, Italy
        • Ospedale
      • Brescia, Italy, 25100
        • Azienda Spedali Civili
      • Catania, Italy
        • Ospedale Ferrarotto
      • Ferrara, Italy, 44100
        • Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
      • Firenze, Italy
        • Policlinico di Careggi, Università delgi studi di Firenze
      • Genova, Italy
        • Clinica Ematologica - Università degli Studi
      • Genova, Italy
        • Universita di Genova
      • Genova, Italy
        • Università degli Studi
      • Lecce, Italy, 73100
        • ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
      • Messina, Italy
        • A.O. Universitaria Policlinico Martina di Messina
      • Milano, Italy, 20132
        • U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele
      • Napoli, Italy
        • Federico II
      • Orbassano, Italy
        • Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
      • Palermo, Italy, 90146
        • Ospedale Cervello
      • Palermo, Italy
        • Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
      • Ravenna, Italy
        • Dipartimento Oncologico - Ospedale S.Maria delle Croci
      • Reggio Calabria, Italy
        • Ospedale
      • Rimini, Italy
        • Ospedale
      • Rionero in Vulture, Italy
        • U.O. di Ematologia - Centro Oncologico Basilicata
      • Roma, Italy
        • Ematologia - Sapienza Università di Roma
      • Rome, Italy, 00168
        • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
      • San Giovanni Rotondo, Italy
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Siena, Italy, 53100
        • U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
      • Taranto, Italy
        • Ospedale
      • Torino, Italy
        • SCDO Ematologia 2 AOU S. Giovanni Battista
      • Udine, Italy, 33100
        • Policlinico Universitario - Clinica Ematologia
      • Verona, Italy, 37134
        • Policlinico G. B. Rossi - Borgo Roma
    • Potenza
      • Rionero in Vulture, Potenza, Italy
        • Centro Oncologico Basilicata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: At one year from study entry
At one year from study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complete haematologic remission t
Time Frame: At one year from study entry
Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses.
At one year from study entry
Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death
Time Frame: At one year from study entry
At one year from study entry
Event Free Survival (EFS)
Time Frame: At one year from study entry
At one year from study entry
Progression Free Survival (PFS)
Time Frame: At one year from study entry
At one year from study entry
Rate of point mutations before or after Nilotinib treatment
Time Frame: At one year from study entry
At one year from study entry
Rate of major cytogenetic response
Time Frame: At one year from study entry
Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses.
At one year from study entry
Rate of compete cytogenetic response
Time Frame: At one year from study entry
Rate of complete cytogenetic response with Nilotinib treatment and the duration of the responses.
At one year from study entry
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.
At one year from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2012

Primary Completion (Actual)

November 24, 2016

Study Completion (Actual)

November 24, 2016

Study Registration Dates

First Submitted

November 11, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 21, 2011

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CML0609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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