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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 because the information has not been verified recently.
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
Endpoint Classification: Efficacy Study
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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Sheba Medical Center

Additional 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
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms by Histologic Type
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 25, 2014