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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
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00297570
First received: February 27, 2006
Last updated: October 7, 2007
Last verified: October 2007
History of Changes
  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 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:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

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

No publications provided by Sheba Medical Center

Additional 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
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:
CML
Imatinib
Pegylated Interferon
Philadelphia Positive CML

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

ClinicalTrials.gov processed this record on May 21, 2013