newly-diagnosed chronic-phase Chronic myeloid leukaemia (CML) MedDRA version: 9.1 Level: LLT Classification code 10009013 Term: Chronic myeloid leukaemia
Conditions
Interventions
Trade Name: Glivec
Pharmaceutical Form: Film-coated tablet
Trade Name: Sprycel
Pharmaceutical Form: Film-coated tablet
Sponsors
Newcastle-upon-Tyne Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients 18 years of age or older. 2. Patients must have all of the following: i) be enrolled within 3 months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis), ii) cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations; patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome. iii) (a) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, nilotinib); busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; any other investigational agents (hydroxyurea 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 3 or greater. 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 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: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to Study Day 1, and (d) male or female of childbearing potential unwilling to use barrier contr! aceptive precautions throughout the trial (postmenopausal women must b e amenorrheaic 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare 5-year Event Free Survival (EFS) between the two treatment arms. The study is powered to demonstrate superiority of the dasatinib arm over the imatinib arm. ;Secondary Objective: 1. To compare the rate of complete cytogenetic response after two years of study therapy in each of the treatment arms and the cumulative incidence of such responses with each of the regimens. The study is powered to demonstrate superiority of the dasatinib arm over the imatinib arm. 2. To compare the treatment faliure rates (TFR) at 5 years between the two arms of the study 3. To compare the rates of complete haematologic response (CHR) in patients treated with these regimens in each of the treatment arms 4. To compare the level of 'molecular response (BCR-ABL/ABL ratio by real time PCR) in each of the treatment arms 5. To compare the tolerability between the regimens. This will in part be incorporated into the treatment failure assessment. 6. To assess quality of life between the regimens 7. To assess the broad comparative costs between the regimens 8. To compare overall survival at 2 and 5 years ;Primary end point(s): To compare 5-year Event Free Survival (EFS) between the two treatment arms. | — |
Countries
United Kingdom
Outcome results
None listed