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Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia

NCT01460693 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 814

Last updated 2018-04-24

No results posted yet for this study

Summary

Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates an 89% probability of progression-free survival. Imatinib is not tolerated or effective in some patients however, and a proportion of patients become resistant to the drug. SPIRIT 2 study aims to establish whether a new drug, dasatinib, is superior to imatinib in terms of event free survival and therefore will be an effective first-line therapy for newly-diagnosed CML patients. This study will also provide crucial long-term survival, quality of life and health economic data to assist health care providers and managers to determine the most cost-effective drug therapy for CML.

Conditions

  • Myeloid Leukemia, Chronic, Chronic Phase

Interventions

DRUG

Imatinib

Oral Imatinib 100mg daily

DRUG

Dasatinib

Oral Dasatinib 100mg daily

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • Hammersmith Hospitals NHS Trust

    collaborator OTHER

  • Newcastle University

    lead OTHER

Principal Investigators

  • Stephen G O'Brien, MD · Newcastle University

  • Richard E Clark, MD · Royal Liverpool University Hospital

  • Jane Apperley, MD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2018-03-07
Completion
2018-03-07

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT01460693 on ClinicalTrials.gov