DIRECT (Dasatinib Intensity Regulation to Eliminate Cumulative Toxicities).
ACTRN12616000738426
Treatment
Phase 2
Commercial sector/Industry,Bristol Myers Squibb
Dr David Yeung
The primary purpose of this study is to evaluate the efficacy and safety of individualised dosing of dasatinib for elderly patients with chronic myelogenous leukaemia. Who is it for? You may be eligible to participate in this study if you are aged 18 years or over, and have been diagnosed with chronic myelogenous leukaemia in the chronic phase (CML-CP) in the previous three months. Study details All participants in this study will start taking dasatinib at 100mg per day. At day 7, a blood sample .... Read more
1. Newly diagnosed CML-CP who have had either no prior exposure or less than 1 month of exposure to alternative TKI therapy a) Must demonstrate a quantifiable BCR-ABL1 fusion transcript on molecular studies, reported on the international scale; and b) Must have morphological appearance consistent with CML-CP, as defined by the European Leukaemia Net criteria.1 Additional cytogenetic abnormalities at baseline or diagnosis do not classify a patient as accelerated phase for the purpose of this stud .... Read more
1. Patients who have undergone major surgery within the 4 weeks prior to study entry or have not recovered from earlier surgery. 2. Impaired cardiac function, uncontrolled or significant cardiovascular disease, including any of the following: a) A myocardial infarction within 6 months b) Uncontrolled angina within 3 months c) Congestive heart failure within 3 months d) Diagnosed or suspected congenital long QT syndrome e) Any history of clinically significant ventricular arrhythmias (such as ven .... Read more
No
Sample Size 80
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Chronic Myelogenous Leukaemia in Chronic Phase
Condition code Cancer
Intervention code Treatment: Drugs
Patients will be treated with Oral Dasatinib at one of 4 dose levels: Dose level 0 = 100mg daily; Dose level -1 = 70mg daily; and Dose level -2 = 50mg daily. Dose level -3 = 50mg alternate daily (exists in this protocol only for treatment re-introduction in the event of treatment cessation for toxicity). All patients will commence treatment with dasatinib at 100mg once daily. Dose adjustments may occur at day 7, 28 and 56. In general, a therapeutic drug monitoring (TDM) result should be availabl .... Read more
Control group Uncontrolled
No control group
Outcome: The primary objective of the DIRECT study is to assess the incidence of treatment related pleural effusion in CML-CP patients, treated with TDM dose optimised dasatinib. This will be assessed by the cumulative incidence of pleural effusions of all grades, at 24 months, in CML-CP patients, treated with TDM dose optimised dasatinib. A chest X-Ray will be performed at baseline, then at the 24 month time point, or for early trial withdrawal. Additional chest X-rays will be .... Read more
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: Any location
Any type of analysis Assessed on a case-by-case basis