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Intermittent Imatinib Treatment in Chronic Myeloid Leukemia and Philadelphia Chromosome (Ph+CML) Patients Who Achieved a Complete Cytogenetic Response (CCgR) on Standard Imatinib Therapy

NCT00858806 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2014-12-03

No results posted yet for this study

Summary

Standard therapy with Imatinib (IM) significantly prolongs the survival of Ph+CML patients who obtain a complete cytogenetic response (CCgR). Elderly patients (i.e., at least 65 years) have similar cytogenetic responses and survival, but they usually show a low compliance. The aim of the study is to evaluate the percentage of elderly patients who maintain a CCgR with intermittent imatinib therapy with respect to standard daily administration.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Imatinib

Intermittent Imatinib administration. * 1 week on / 1 week off for the 1st month(weeks 1-4) * 2 weeks on / 2 weeks off for the 2nd and the 3rd month (weeks 5-12) * 1 month on / 1 month off from the 4th month thereafter (weeks 13 on)

Sponsors & Collaborators

  • Università degli Studi di Brescia

    lead OTHER

Principal Investigators

  • Prof Domenico Russo, MD · Chair of Haematology, Brescia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-12-31
Completion
2014-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00858806 on ClinicalTrials.gov