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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Sheba Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Sheba Medical Center Identifier:
First received: February 27, 2006
Last updated: October 7, 2007
Last verified: October 2007
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 Intervention Phase
Leukemia, Myeloid, Philadelphia-Positive Drug: Pegylated Interferon and Imatinib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 90
Study Start Date: February 2006

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00297570

Contact: Izhar Hardan, MD +972 3 5302174

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00297570     History of Changes
Other Study ID Numbers: SHEBA-06-4015-IH-CTIL
Study First Received: February 27, 2006
Last Updated: October 7, 2007

Keywords provided by Sheba Medical Center:
Pegylated Interferon
Philadelphia Positive CML

Additional relevant MeSH terms:
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 processed this record on June 23, 2017