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

NCT ID: NCT00297570

Last Updated: 2007-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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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

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Conditions

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Leukemia, Myeloid, Philadelphia-Positive

Keywords

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CML Imatinib Pegylated Interferon Philadelphia Positive CML

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pegylated Interferon and Imatinib

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Izhar Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Department of Hematology, Sheba Medical Center

Tel Litwinsky, Tel-Hashomer, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Izhar Hardan, MD

Role: CONTACT

Phone: +972 3 5302174

Email: [email protected]

References

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Hardan I, Stanevsky A, Volchek Y, Tohami T, Amariglio N, Trakhtenbrot L, Koren-Michowitz M, Shimoni A, Nagler A. Treatment with interferon alpha prior to discontinuation of imatinib in patients with chronic myeloid leukemia. Cytokine. 2012 Feb;57(2):290-3. doi: 10.1016/j.cyto.2011.11.018. Epub 2011 Dec 13.

Reference Type DERIVED
PMID: 22169779 (View on PubMed)

Other Identifiers

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SHEBA-06-4015-IH-CTIL

Identifier Type: -

Identifier Source: org_study_id