A multicenter, open label, randomized, phase III clinical trial to evaluate efficacy & safety of PF 114 versus imatinib at 600 or 800 mg daily in adult patients with Philadelphia chromosome positive (Ph positive) chronic myeloid leukemia (CML) in the chronic phase (CP) resistant to imatinib at daily doses of 400 or 600 mg

JSC PHARMASYNTEZNORD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年12月19日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. The patient has given an informed consent to participate in this study; there is an informed consent form signed by the patient and the investigator;
•2. Men and women aged 18 years old and over;
•3. Confirmed diagnosis of Philadelphia chromosome positive chronic myeloid leukemia in the chronic phase according to the listed criteria of the European LeukemiaNet (ELN) Guidelines: - 100 x 109 platelets/L in peripheral blood, - Absence of clonal chromosomal abnormalities;
•4. Resistance to imatinib treatment in a daily dose of 400 or 600 mg (see Appendix 6);
•5. Patients previously not treated with any Bcr-Abl tyrosine kinase inhibitors other than imatinib, or duration of such drug treatment less than 1 week;
•6. The presence of the standard BCR-ABL1 p210 transcript according to the data of the previous analysis;
•7. Performance status according to Eastern United Oncological Group (ECOG) 0 to 1;
•8. Satisfactory renal function, i.e. serum creatinine = 1.5 x ULN (upper limit of normal);
•9. Satisfactory liver function according to the following criteria:
•Serum total bilirubin = 1,5 x ULN except for patients diagnosed with Gilbert’s syndrome; • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2,5 x ULN;
•Alkaline phosphatase = 2,5 x ULN; • INR = 1,5 x ULN;
•10. Satisfactory heart function, i.e. left ventricular ejection fraction above 40% according to echocardiography
•11. QTcF interval = 450 ms for men and = 470 ms for women during ECG assessment at screening;
•12. The consequences of previous therapy resolved to severity grade 1 or lower according to NCI CTC AE v5 (except for alopecia);
•13. For women of childbearing potential, as well as men who have female partners of childbearing potential, consent to abstain from sexual intercourse or to use effective methods of contraception for the entire study period;

排除标准

•1. Patients received imatinib therapy in a daily dose above 600
•2. Patients with a major molecular response according to the
•results of the last test with molecular response assessment;
•3. A history of imatinib intolerability, defined as the presence of
•grade 3 or 4 adverse reactions according to NCI CTC AE v5
•during imatinib therapy, without satisfactory management with
•concomitant therapy or requiring imatinib dose reduction;
•4. Presence of BCR-ABL1 mutations indicating high resistance to
•imatinib therapy: L248V, Q252R, Y253H/F, E255K/V,
•T315I/D, F317L, F486S;
•5. Known intolerability of PF-114 components;
•6. Use of the following previous treatment:
•a. chemotherapy drugs within 21 days before the first dose of
•the study drug (except for hydroxycarbamide, which does
•not require drug elimination from the body) or nitrosoureaderived drugs, as well as mitomycin C within 42 days before the first dose of the study drug;
•b. tyrosine kinase inhibitors, including approved and
•experimental drugs, within 4 days before the first dose of the
•study drug, except for imatinib in a constant daily dose of
•400 mg or 600 mg for 2 or more weeks. Patient should not
•receive imatinib within 12 hours before the study drugs
•administration;
•c. radiation therapy within 28 days before the first dose of the
•study drug;
•d. autologous or allogeneic hematopoietic stem cell
•transplantation;
•e. herbal medicines within 2 weeks before the first PF-114
•administration. The exception is cold medicines, if the
•patient takes them for no more than 7 days;
•f. potent inhibitors and potent inducers of CYP3A4 within 2
•weeks before the study initiation.
•7. Presence of clinically significant uncontrolled cardiovascular
•8. Uncontrolled arterial hypertension grade 2 or higher according
•to NCI CTC AE v5;
•9. The patient is receiving drugs that are known to prolong the QT
•interval on the ECG only if they are not vital for the patient in
•the investigator’s opinion;
•10. Acute pancreatitis in medical history within 1 year before
•enrollment into the study, chronic pancreatitis or alcohol
•dependence;
•11. Evidence of active graft versus host disease (GVHD) or GVHD
•requiring immunosuppressive therapy. Immunosuppressive
•therapy for prevention or treatment within 14 days before the
•first dose of PF-114;
•12. Major surgery within 35 days;
•13. Uncontrolled concomitant disease, including but not limited to
•the following: active systemic infection; uncontrolled seizure
•disorders; mental illnesses or social obstacles that prevent the
•patient from compliance with all the requirements of the
•protocol procedures or interfere with the study results;
•14. Inability to swallow the drug, or gastrointestinal diseases that
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研究者

发起方

JSC PHARMASYNTEZNORD

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