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Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297570
Recruitment Status : Unknown
Verified October 2007 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : February 28, 2006
Last Update Posted : October 10, 2007
Information provided by:
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Philadelphia-Positive Drug: Pegylated Interferon and Imatinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00297570

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Contact: Izhar Hardan, MD +972 3 5302174

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Department of Hematology, Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Principal Investigator: Izhar Hardan, MD         
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Izhar Hardan, MD Sheba Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00297570    
Other Study ID Numbers: SHEBA-06-4015-IH-CTIL
First Posted: February 28, 2006    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: October 2007
Keywords provided by Sheba Medical Center:
Pegylated Interferon
Philadelphia Positive CML
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action