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Efficacy and Safety Study of Dasatinib in Patients With Chronic Myeloid Leukemia

NCT00895297 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-12-07

No results posted yet for this study

Summary

This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia (CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other treatment, such as imatinib therapy.

A relapse is when an illness that has seemed to be getting better, or to have been cured, comes back or gets worse again.

A total of 50 patients ≥18 years of age will be registered on the trial.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Dasatinib (Sprycel)

100mg of Dasatinib will be administered as tablets, by mouth, once a day (or twice in some cases depending on the stage of the disease) consistently either in the morning or evening for 12 months. Dose of Dasatinib will be modified according to the patients response.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Eduardo L Olavarria, Dr · Hospital De Navarra Irunlarrea, Spain

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-10-31
Completion
2011-11-30

Countries

  • France
  • Germany
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00895297 on ClinicalTrials.gov