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

This study is currently recruiting participants.

Verified by Sheba Medical Center, October 2007

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00297570

Purpose

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 III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Sheba Medical Center:

Estimated Enrollment:	90
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Study ID Numbers:	SHEBA-06-4015-IH-CTIL
Study First Received:	February 27, 2006
Last Updated:	October 7, 2007
ClinicalTrials.gov Identifier:	NCT00297570
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

CML
Imatinib
Pegylated Interferon
Philadelphia Positive CML

Study placed in the following topic categories:

Imatinib
Leukemia
Hematologic Diseases
Interferons

Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009