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NCT Number: NCT01475110

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

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.

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Key information

Conditions

Chronic Myeloid Leukaemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Oncologico Basilicata, Rionero in Vulture, Potenza, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imatinib

Drug

Observation of Imatinib resistant patients treated with Nilotinib.

Primary outcomes

  1. Overall Survival

    Time frame: At one year from study entry

Secondary outcomes

  1. 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.

  2. Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death

    Time frame: At one year from study entry

  3. Event Free Survival (EFS)

    Time frame: At one year from study entry

  4. Progression Free Survival (PFS)

    Time frame: At one year from study entry

  5. Rate of point mutations before or after Nilotinib treatment

    Time frame: At one year from study entry

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study 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

Acronym: CML0609

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2011
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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