Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia … (NCT04150471) | Clinical Trial Compass
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Assess Long-term Feasibility of Reduced Dose Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients
South Korea79 participantsStarted 2018-10-18
Plain-language summary
This study is conducted in patients with newly diagnosed CP CML (Chronic Phase Chronic Myeloid Leukemia) who have achieved EMR (\< 10% IS BCR-ABL) at 3 months after first line treatment with dasatinib. Subjects will be allocated to 80mg QD based on EMR (Early Molecular Response) achievement and early safety profile following a standard of care approach.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adult CML-CP Ph+ (Philadelpia) patients with BCR-ABL1 patients diagnosed within 3 months
* Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN(Upper limit of normal)
* Adequate hepatic function defined as: total bilirubin ≤ 2 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the institutional upper limit of normal (ULN).
* Adequate cardiac function (see exclusion criteria)
* Adequate pulmonary function (see exclusion criteria)
* Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or equal to the institutional lower limit of normal. Subjects with low K, Mg levels, total serum Ca and/or ionized Ca must be replete to allow for protocol entry: Rescreening is permitted in the event of temporary biochemical abnormalities
* CML-CP Ph+ patients with CHR but with BCR-ABL level \< 10% IS after 3 months of frontline dasatinib 100 mg treatment. And currently persisting any grade adverse events to dasatinib 100 mg QD
* ECOG(Eastern Cooperative Oncology Group) performance status 0-2
* Women must not be pregnant
Exclusion Criteria:
* Previous diagnosis of accelerated phase or blast crisis
* Documented any major ABL1 mutation
* A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive dasatinib
* Pulmonary arterial hypertension
* Congenital bleeding disorders
* Prior or concurrent malignancy, ex…