Back to resultsImatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy
Primary Purpose
Leukemia, Myeloid, Philadelphia-Positive
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Pegylated Interferon and Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Philadelphia-Positive focused on measuring CML, Imatinib, Pegylated Interferon, Philadelphia Positive CML
Eligibility Criteria
Inclusion Criteria: Ph+ CML patients in complete cytogenetic response (CCR) after more than 1 year of imatinib therapy. Exclusion Criteria: Patients in imatinib study Patients with a history of intolerability to interferon. Patients with less than CCR or less than one year of imatinib therapy.
Sites / Locations
- Department of Hematology, Sheba Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00297570
First Posted
February 27, 2006
Last Updated
October 7, 2007
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00297570
Brief Title
Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients with complete cytogenetic response after more than one year of imatinib therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN) to imatinib, in terms of the rate of achievement, molecular remission, and response duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Philadelphia-Positive
Keywords
CML, Imatinib, Pegylated Interferon, Philadelphia Positive CML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon and Imatinib
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ph+ CML patients in complete cytogenetic response (CCR) after more than 1 year of imatinib therapy.
Exclusion Criteria:
Patients in imatinib study
Patients with a history of intolerability to interferon.
Patients with less than CCR or less than one year of imatinib therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Izhar Hardan, MD
Phone
+972 3 5302174
Email
izhar.hardan@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Izhar Hardan, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology, Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izhar Hardan, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22169779
Citation
Hardan I, Stanevsky A, Volchek Y, Tohami T, Amariglio N, Trakhtenbrot L, Koren-Michowitz M, Shimoni A, Nagler A. Treatment with interferon alpha prior to discontinuation of imatinib in patients with chronic myeloid leukemia. Cytokine. 2012 Feb;57(2):290-3. doi: 10.1016/j.cyto.2011.11.018. Epub 2011 Dec 13.
Results Reference
derived
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Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy
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