NCT00297570

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

February 27, 2006

Last Update Submit

October 7, 2007

Conditions

Leukemia, Myeloid, Philadelphia-Positive

Keywords

CMLImatinibPegylated InterferonPhiladelphia Positive CML

Interventions

Pegylated Interferon and ImatinibDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ph+ CML patients in complete cytogenetic response (CCR) after more than 1 year of imatinib therapy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Sheba Medical Center

Tel Litwinsky, Tel-Hashomer, 52621, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22169779DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Izhar Hardan, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Izhar Hardan, MD

CONTACT

+972 3 5302174izhar.hardan@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 27, 2006

First Posted

February 28, 2006

Study Start

February 1, 2006

Last Updated

October 10, 2007

Record last verified: 2007-10

Locations

IL(1)