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

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ClinicalTrials.gov Identifier: NCT01188278
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment
Leukemia, Myeloid, Chronic-Phase (CML-CP) Drug: Imatinib

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 173 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
Study Start Date : July 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013


Group/Cohort Intervention/treatment
Patients in CP-CML treated with 2G TKI
Patients in CP-CML treated with 2G TKI (nilotinib or dasatinib) post imatinib failure
Drug: Imatinib
Drug being observed but not provided
Other Names:
  • Dasatinib
  • Nilotinob




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hematology centers (hospitals) which have necessary historical data available
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188278


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01188278    
Other Study ID Numbers: CA180-291
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: October 2013
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action