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Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia (SPIRIT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01460693
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : April 24, 2018
Newcastle-upon-Tyne Hospitals NHS Trust
Bristol-Myers Squibb
Institute of Cancer Research, United Kingdom
Hammersmith Hospitals NHS Trust
Information provided by (Responsible Party):
Newcastle University

Brief 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.

Condition or disease Intervention/treatment Phase
Myeloid Leukemia, Chronic, Chronic Phase Drug: Imatinib Drug: Dasatinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 814 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Prospective Randomised Comparison of Imatinib (STI571, Glivec/Gleevec) 400mg Daily Versus Dasatinib 100mg in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia
Study Start Date : August 2008
Actual Primary Completion Date : March 7, 2018
Actual Study Completion Date : March 7, 2018

Arm Intervention/treatment
Active Comparator: Arm A - Imatinib
Imatinib 400mg daily
Drug: Imatinib
Oral Imatinib 100mg daily
Other Name: Gleevec/Gleevic

Experimental: Arm B - Dasatinib
Dasatinib 100mg daily
Drug: Dasatinib
Oral Dasatinib 100mg daily
Other Name: Sprycel

Primary Outcome Measures :
  1. 5-year event free survival [ Time Frame: ongoing throughout study (5 years) ]
    To compare 5-year event free survival between the 2 treatment arms. The study aim is to show superiority of the dasatinib arm over the imatinib 400mg arm.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients 18 years or over.
  2. Patients must have all of the following:

    • be enrolled within 3 months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis)
    • cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations
    • patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome.
    • < 15% blasts in peripheral blood and bone marrow;
    • < 30% blasts plus promyelocytes in peripheral blood and bone marrow;
    • < 20% basophils in peripheral blood,
    • 100 x 109/L platelets or greater
    • no evidence of extramedullary leukaemic involvement, with the exception of the hepatosplenomegaly.
  3. Written voluntary informed consent.

Exclusion Criteria:

  1. Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study.
  2. Any prior treatment for CML with: any tyrosine kinase inhibitor (eg imatinib, dasatinib); busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; any other investigational agents (hydroxycarbamide and anagrelide are the only drugs permitted). NB patients will be ineligible for the study if they have received ANY prior therapy with interferon-alpha or imatinib. NO exceptions.
  3. Patients who received prior chemotherapy, including regimens used in peripheral blood progenitor cells (PBPCs) mobilisation for haematopoietic progenitor-cell transplantation. (It is allowable to collect unmobilised PBPCs at diagnosis.)
  4. Patient who have had any form of prior haemopoietic stem cell transplant, either autograft or allograft.
  5. Patients with an ECOG Performance Status Score of 2 or less.
  6. Patients with serum bilirubin, SGOT/AST, SGPT/ALT, or creatinine concentrations > 2.0 x the institutional upper limit of the normal range (IULN).
  7. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulants.
  8. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina, or Grade 3/4 cardiac problems as defined by the New York Heart Association Criteria.
  9. Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required.
  10. Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery.
  11. Patients who are:

    • pregnant,
    • breast feeding,
    • of childbearing potential without a negative pregnancy test prior to Study Day 1, and
    • male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
  12. Patients with a history of another malignancy either currently or within the past five years, with the exception of basal cell skin carcinoma or cervical carcinoma in situ.
  13. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01460693

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United Kingdom
Freeman Hospital
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
Bristol-Myers Squibb
Institute of Cancer Research, United Kingdom
Hammersmith Hospitals NHS Trust
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Principal Investigator: Stephen G O'Brien, MD Newcastle University
Principal Investigator: Richard E Clark, MD Royal Liverpool University Hospital
Principal Investigator: Jane Apperley, MD Imperial College London
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Newcastle University Identifier: NCT01460693    
Other Study ID Numbers: 4443
2007-006185-15 ( EudraCT Number )
ISRCTN54923521 ( Other Identifier: ISRCTN )
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Keywords provided by Newcastle University:
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action