Condition category
Cancer
Date applied
17/04/2008
Date assigned
09/10/2008
Last edited
20/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.newcastle-hospitals.org.uk

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

Publication citations

Additional files

Editorial Notes