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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 27, 2006

Last Updated Date

October 7, 2007

Start Date ^†

February 2006

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00297570 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Leukemia, Myeloid, Philadelphia-Positive

Intervention ^†

Drug: Pegylated Interferon and Imatinib

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Izhar Hardan, MD

+972 3 5302174

izhar.hardan@sheba.health.gov.il

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00297570

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Sheba Medical Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Izhar Hardan, MD

Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

October 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.