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Completed

NCT Number: NCT01188278

Treatment With Second Generation Tyrosine Kinase Inhibitors (2G TKI) Post Imatinib Failure Survey

The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).

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Key information

Conditions

Leukemia, Myeloid, Chronic-Phase (CML-CP) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Historic cohort prolonged by a 12-month follow-up period.

Prospective: look forward using periodic observations collected predominantly following subject enrollment: one year of follow up of patients with CP-CML alive at the time of the study.

Retrospective: look back using observations collected predominantly prior to subject selection and enrollment : historical data of patients with CP-CML initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-June-2009.

The inclusion of a historical cohort will allow a rapid enrollment of a large number of patients of this rare pathology, while the prospective follow up of this cohort would allow long term data to be obtained, including the assessment of the impact on survival and appreciate the patient's quality of life (QoL), compliance and satisfaction.

Who can participate

Healthy volunteers accepted: No

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

Patients with Additional Chromosomal Anomalies (ACA) are accepted to be in CP. Patients enrolled in open-label clinical trials or other observational trials are also allowed (unless explicitly prohibited by the trial).

This trial does not prohibit participation in other observational trials.

Inclusion criteria

  • Patients diagnosed with CP-CML. (ACA) are allowed
  • Age >18 years old
  • Prior treatment with imatinib monotherapy as first line treatment, to which the patient is deemed resistant or intolerant.Patients treated by INF and/or AraC prior (but not concomitant) to imatinib are eligible.
  • Initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-Jun-2009.

Exclusion criteria

  • Patients in (or with history of) accelerated or blastic phase CML
  • Patients treated by allogeneic stem cell transplantation.
  • Any other CML treatment except for INF and/or AraC,and a short period of Hydroxyurea or Anagrelide prior to imatinib.
  • Patients treated with 2G TKI for reasons other than imatinib failure.
  • Patients with no historical data (e.g. possibility of Sokal Score calculation) available.
  • Patients participating in clinical or observational trials which explicitly prohibit enrollment in non interventional studies.

Treatment and study plan

Imatinib

Drug

Drug being observed but not provided

Other names: Dasatinib, Nilotinob

Primary outcomes

  1. Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)

    Time frame: CCyR at 6 month of 2GTKI treatment

    The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR), as assessed by the following:

    • Distribution of patients according to Hammersmith score levels
    • Characterization of association between Hammersmith score and occurrence of CCyR
    • Assessment of capacity of Hammersmith score to predict CCyR, using diagnostic test assessment methods.

    This score is measured at the time of imatinib failure.

Secondary outcomes

  1. Predictive value of Hammersmith score on Major Molecular Response (MMR)

    Time frame: MMR at 3 month of 2GTKI treatment

    The purpose of this study is to determine predictive value of Hammersmith score on Major Molecular Response(MMR), as assessed by the following:

    • Distribution of patients according to Hammersmith score levels
    • Characterization of association between Hammersmith score and occurrence of MMR
    • Assessment of capacity of Hammersmith score to predict MMR, using diagnostic test assessment methods.

    This score is measured at the time of imatinib failure.

  2. Predictive factors of Overall survival (including Hammersmith score, MMR at 3 months and CCyR at 6 months of 2G TKI treatment together with patients, disease and treatment characteristics)

    Time frame: From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death

  3. Predictive value of Hammersmith score compared to other factors

    Time frame: From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death

    imatinib treatment duration, mutations at time of failure, best response to imatinib, time between imatinib failure & initiation of 2G TKI on the response to 2G TKI & on the survival end points (Overall Survival (OS)& Progression Free Survival (PFS)).

  4. Patients populations (socio-demographic data, medical history, disease history, co morbidities treated with 2G TKI

    Time frame: When occurs the switch from Imatinib to 2G TKI between 01Jan2005 and 30Jun2009

  5. Patients' satisfaction, Quality of life & compliance to treatment in patients treated with 2G TKIs

    Time frame: For all alive patients treated with 2G TKI during the enrolment period (Jun2010 to Oct2010)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 25, 2010
Registry last updated
Sep 30, 2016

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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