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

Leukemia, Myeloid, Philadelphia-Positive Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00297570
• Other study ID #: SHEBA-06-4015-IH-CTIL
• Status: Recruiting
• Phase: Phase 3
• First received: February 27, 2006
• Last updated: October 7, 2007
• Start date: February 2006

Study information

• Verified date: October 2007
• Source: Sheba Medical Center
• Contact: Izhar Hardan, MD
• Phone: +972 3 5302174
• Email: izhar.hardan[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Philadelphia-Positive

Intervention

Drug:
• Pegylated Interferon and Imatinib

Locations

Country	Name	City	State
Israel	Department of Hematology, Sheba Medical Center	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel,