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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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ClinicalTrials.gov 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
Sponsor:
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

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






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

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): NCT00297570


Contacts
Contact: Izhar Hardan, MD +972 3 5302174 izhar.hardan@sheba.health.gov.il

Locations
Israel
Department of Hematology, Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Principal Investigator: Izhar Hardan, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Izhar Hardan, MD Sheba Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00297570     History of Changes
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:
CML
Imatinib
Pegylated Interferon
Philadelphia Positive CML

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferons
Imatinib Mesylate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action