Status:
COMPLETED
Intermittent Imatinib Treatment in Chronic Myeloid Leukemia and Philadelphia Chromosome (Ph+CML) Patients Who Achieved a Complete Cytogenetic Response (CCgR) on Standard Imatinib Therapy
Lead Sponsor:
Università degli Studi di Brescia
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
Standard therapy with Imatinib (IM) significantly prolongs the survival of Ph+CML patients who obtain a complete cytogenetic response (CCgR). Elderly patients (i.e., at least 65 years) have similar cy...
Detailed Description
Objective: The aim of the study is to investigate if the complete cytogenetic response (CCgR) that has been achieved with standard (daily administration) Imatinib (IM) therapy can be maintained with t...
Eligibility Criteria
Inclusion
- Patients with confirmed diagnosis of Ph+ CML in CP
- Age ≥ 65 years old
- Stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month
- Karnofsky performance status \>50%
- Written informed consent prior to any study procedures being performed.
Exclusion
- Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP, previously treated (i.e. IFN alpha+/- low dose Ara-C, Hydroxyurea, allogeneic stem cell transplantation, etc etc.)
- Age \< 65 years old
- No stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month
- Karnofsky performance status \<50%
- No written informed consent prior to any study procedures being performed.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00858806
Start Date
April 1 2008
End Date
December 1 2014
Last Update
December 3 2014
Active Locations (1)
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1
Chair of Haematology, Bone Marrow Transplant Unit
Brescia, Brescia, Italy, 25123