A single arm phase II study to individualize dasatinib dosing based on trough levels and molecular response to maintain efficacy whilst minimising toxicity (CML12)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 80 patients over 60 with newly diagnosed CML, using desatinib and monitoring lung function Diagnostic data, treatment data, outcome data Cancer Australia demographic data -Year of birth -Aboriginal or Torres Strait Islander status (or Ethnicity)
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Source Study

Trial acronym

DIRECT (Dasatinib Intensity Regulation to Eliminate Cumulative Toxicities).

Trial ID





Phase 2


Commercial sector/Industry,Bristol Myers Squibb

Scientific enquiries

Dr David Yeung

Brief Summary

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 ....
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Key Inclusion Criteria

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 ....
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Key Exclusion Criteria

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 ....
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Can healthy volunteers participate?




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 ....
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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 ....
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Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data, for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: Any location

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see