Treatment Modification Based on Early Assessment of CML Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Rabin Medical Center
Sponsor:
Collaborators:
Rambam Health Care Campus
Wolfson Medical Center
Bnai Zion Medical Center
HaEmek Medical Center, Israel
Hadassah Medical Organization
Information provided by (Responsible Party):
LIAT VIDAL FISHER, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01762969
First received: January 6, 2013
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

The investigators will check the feasibility of using early molecular response for making treatment decisions. Patients diagnosed with chronic myeloid leukemia will commence imatinib treatment. After 3 months of treatment their response will be assessed. If molecular response would be less the 10% (BCR-ABL1/ABL ISI >10%)imatinib therapy will be stopped and patients will start a different TKI (as nilotinib, dasatinib). The investigators will follow on lab and clinical outcomes.


Condition Intervention Phase
CML
Other: Treatment modification based on molecular response at 3 months
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modification of Imatinib to Other Tyrosine Kinase Inhibitors Dependent on 3-months Molecular Response of CML Patients

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Rate of complete cytogenetic response [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of major molecular response [ Time Frame: 12, 24 months ] [ Designated as safety issue: No ]
    Cumulative rate of optimal response at 12, 18 months

  • PFS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time from commencement of imatinib till meeting ELN criteria for failure, progression to AP/BC, or death from any cause

  • Severe Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse events will be classified according to the CTCAE NCI US v.3.0


Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified by molecular response
Patients will be treated with imatinib upon diagnosis of CML. Molecular response will be assessed at 3 months of therapy. Based on molecular response imatinib will be continued or changed to another TKI
Other: Treatment modification based on molecular response at 3 months
Patients will be treated with imatinib upon diagnosis of CML. Molecular response will be assessed at 3 months of therapy. Based on molecular response imatinib will be continued or changed to another TKI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Adult patients within 6 months after the diagnosis of Philadelphia chromosome-positive CML in the chronic phase

    1. who were not previously treated (with the exception of hydroyurea) for CML or
    2. who were treated with imatinib for CML for up to 3 months, and prior to 3 months assessment (patients will be excluded if they received treatment with a tyrosine kinase inhibitor other than imatinib).

      2. Age > 18 years Diagnosis of CML will be made by conventional cytogenetic (chromosome banding analysis) and/or interphase fluorescent in situ hybridization (FISH) analysis of bone marrow containing at least one Philadelphia chromosome-positive metaphase cell. If BCR-ABL1 fusion gene (Philadelphia chromosome) is not detected by conventional cytogenetic analysis, the diagnosis of CML can be confirmed based on FISH analysis or molecular analysis (demonstration of bcr-abl by polymerase chain reaction (PCR)).

      Inclusion of patients with any organ dysfunction (cardiac, renal, respiratory, liver) can be done based on the decision of the treating physician.

      Exclusion Criteria:

      Patients will be excluded if they received treatment with a tyrosine kinase inhibitor other than imatinib (i.e., nilotinib, dasatinib) before study entry. Patients may take hydroxyurea or anagrelide for up to 4 weeks prior to imatinib treatment.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762969

Contacts
Contact: Liat vidal, MD MSc vidallit@yahoo.com
Contact: Ofer Shpilberg, MD MPH +972-3-9377906

Locations
Israel
Rabin Medical Center Recruiting
Petah tikva, Israel, 49100
Contact: Liat vid       vidallit@yahoo.com   
Contact: Ofer , Shpilberg         
Sponsors and Collaborators
Rabin Medical Center
Rambam Health Care Campus
Wolfson Medical Center
Bnai Zion Medical Center
HaEmek Medical Center, Israel
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: LIAT VIDAL FISHER, Dr., Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01762969     History of Changes
Other Study ID Numbers: CML-IS001
Study First Received: January 6, 2013
Last Updated: January 7, 2013
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014