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

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ClinicalTrials.gov Identifier: NCT01475110
Recruitment Status : Unknown
Verified October 2018 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Recruiting
First Posted : November 21, 2011
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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 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.

Condition or disease Intervention/treatment
Chronic Myeloid Leukaemia Drug: Imatinib

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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
Study Start Date : February 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


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.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: At one year from study entry ]

Secondary Outcome Measures :
  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.



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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
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.
Criteria

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.

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): NCT01475110


Contacts
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Contact: Paola FAZI, Dr. p.fazi@gimema.it
Contact: Enrico CREA e.crea@gimema.it

Locations
Show Show 33 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Giuseppe SAGLIO, Pr. Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01475110    
Other Study ID Numbers: CML0609
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Imatinib
Chronic Myeloid Leukaemia
Nilotinib
Adult patients
Imatinib resistant
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action