Study title
SPIRIT2 = Comparison of imatinib versus dasatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia [Europe]
Scientific title
A Phase III, Prospective Randomised Comparison of Imatinib 400mg Daily Versus Dasatinib 100mg in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia (EudraCT 2007-006185-15, ClinicalTrials.gov NCT01460693)
Indication and most important inclusion criteria
Patients can be enrolled within 3 months of initial diagnosis of chronic phase CML and cytogenetic confirmation of Philadelphia chromosome or variants of (9;22) translocations. Patients should be non-treated with any TKI (eg imatinib, dasatinib, nilotinib), busulphan, interferon-alpha, homoharringtonine, cytosine arabinoside, or any other investigational agents.
Short description of intervention
Comparison of 5-year event free survival between two treatment arms receiving either dasatinib 100mg or imatinib 400mg. The study aim is to show superiority of the dasatinib arm over the imatinib arm.
Type of study
First line trial
Current status
Recruitment complete - In follow-up
Study sponsor
Newcastle-upon-Tyne NHS Hospitals (Main Sponsor),
Bristol-Myers Squibb (Funder)
Scientific lead / contact
O'Brien, MD, Stephen
Newcastle University Medical School
stephen.o'brien@newcastle.ac.uk
Principal investigator
Stephen O'Brien, MD
SPIRIT Trial Office
International Centre for Life
Newcastle upon Tyne, UK
Additional information
Short protocol in European LeukemiaNet
Study centers / principal investigators
> 150 study centres
Members of trial management committee are based at:
Newcastle upon Tyne, UK
Newcastle University Medical School
Liverpool, UK
Royal Liverpool University Hospital
London, UK
Imperial College London
Philadelphia chromosome
A certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene)
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Chronic phase
The earliest phase of CML development.
Chromosome
A chromosome is a structure of DNA that carries the genetic makeup in the nucleus of the cell. Chromosomes contain giant chain molecules of DNA, coiled and folded as aggregates with specific proteins. Chromosomes ensure that during cell division the hereditary information is evenly distributed to the daughter cells. Normal human body cells have 46 chromosomes. Cancer cells can have a different number and/or structure of chromosomes.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Dasatinib
Trade name: Sprycel, development name: BMS-354825, inhibits BCR-ABL and SRC tyrosine kinases. Authorized for marketing in the EU since 2006 for the treatment of CML and Ph+ALL.
Other names: BMS-354825|BMS354825|Sprycel
Nilotinib
Trade name: Tasigna, development name: AMN107, inhibits BCR-ABL tyrosine kinase. Authorized for marketing in the EU since 2007 for the treatment of CML and Ph+ALL.
Other names: |AMN107|Tasigna
Protocol
The action plan for the research work, which explains key objectives and procedures. In case of a clinical trial, the protocol defines e.g. the purpose of the study, how many people will participate, eligibility criteria, the medical intervention, etc.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
Chronic
Long-lasting, slowly developping
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
