Contact information
Type
Scientific
Primary contact
Ms Corinne Hedgley
ORCID ID
Contact details
Newcastle University
Academic Haematology
School of Clinical & Laboratory Sciences
Leech Building
Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)1280 814 916
c.a.hedgley@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01460693
Protocol/serial number
4443
Study information
Scientific title
STI571 Prospective International RandomIsed Trial 2: A phase III, prospective randomised comparison of imatinib (STI571, Glivec®/ Gleevec®) 400 mg daily versus dasatinib (Sprycel®) 100 mg daily in patients with newly-diagnosed chronic phase chronic myeloid leukaemia
Acronym
SPIRIT 2
Study hypothesis
To compare 5-year Event Free Survival (EFS) between the treatment arms. The study is powered to demonstrate superiority of the dasatinib arm over the imatinib arm.
Ethics approval
London Research Ethics Committee in 11/2007 (ref: 07/H0718/90)
Study design
Phase III, multicentre, open-label, prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Newly diagnosed, chronic-phase, chronic myeloid leukaemia
Intervention
Arm 1: Imatinib (oral) 400 mg daily, to be taken for a minimum of 5 years
Arm 2: Dasatinib (oral) 100 mg daily, to be taken for a minimum of 5 years
All endpoints will be assessed at regular timepoints throughout the trial for a minimum of 5 years per patient.
Contact details of Principal Investigator:
Dr Stephen O'Brien
Newcastle University
Academic Haematology
School of Clinical & Laboratory Sciences
Leech Building, Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
Intervention type
Drug
Phase
Phase III
Drug names
STI571 (Glivec®/ Gleevec®) and dasatinib (Sprycel®).
Primary outcome measures
Event -free survival at 5 years
Secondary outcome measures
1. To compare the rate of complete cytogenetic response after 2 years
2. To compare the treatment failure rates (TFR) at 5 years
3. To compare the rates of complete haematologic response (CHR). Duration of follow-up: 60 months
4. To compare the level of 'molecular' response (BCR-ABL/ABL ratio by real time polymerase chain reaction [PCR]). Duration of follow-up: 60 months
5. To compare the tolerability between the regimens. This will in part be incorporated into the treatment failure assessment. Duration of follow-up: 60 months
6. To assess quality of life by the EQ-5D and the Functional Assessment of Cancer Treatment-Biological Response Modifier (FACT-BRM) questionnaires. Timepoints of assessment: at screening and then Months 1, 2, 3, 6, 12, 24, 36, 48, 60
7. To assess the broad comparative costs between the regimens
8. To compare overall survival at 2 and 5 years
Overall trial start date
30/06/2008
Overall trial end date
30/06/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female patients >= 18 years of age
2. Patients must have all of the following:
2.1. Be enrolled within 3 months of initial diagnosis of chronic myeloid leukaemia - chronic phase (CML-CP) (date of initial diagnosis is the date of first cytogenetic analysis)
2.2. Cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations; patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome
2.3. <15% blasts in peripheral blood and bone marrow
2.4. <30% blasts plus promyelocytes in peripheral blood and bone marrow
2.5. <20% basophils in peripheral blood
2.6. >= 100 x 10^9/L platelets
2.7. No evidence of extramedullary leukaemic involvement, with the exception of hepatosplenomegaly
3. Written voluntary informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
810
Participant 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 (e.g., imatinib, dasatinib, nilotinib); 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 Eastern Cooperative Oncology Group (ECOG) Performance Status Score >= 3
6. Patients with serum bilirubin, aspartate aminotransferase (SGOT/AST), alanine aminotransferase (SGPT/ALT), or creatinine concentrations > 2.0 x the institutional upper limit of the normal range
(IULN)
7. Patients with International normalised 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:
11.1 Pregnant
11.2. Breast feeding
11.3. Of childbearing potential without a negative pregnancy test prior to Study Day 1
11.4. Male or female of childbearing potential unwilling to use barrier contraceptive (Amenorrhoeic 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
Recruitment start date
30/06/2008
Recruitment end date
30/06/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle-upon-Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
R&D Department
4th Floor
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Bristol Myers-Squibb (USA)
Alternative name(s)
Bristol-Myers Squibb Company, BMS
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary