SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Официальное название

A Single-Arm, Multicenter, Open-Label, Dose- Escalating and Expanding,Phase I/II Study of SKLB1028 Combined With "7+3" Standard Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Обзор

The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine/ daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .

Вмешательства

• Препарат SKLB1028 Dose Escalation
  Drug :SKLB1028 ;Drug: Cytarabine ;Drug: Daunorubicin

Первичные конечные точки

• Number of participants with dose limiting toxicities (DLTs) [Срок оценки: up to Day42]

Вторичные конечные точки (7)

• Pharmacokinetics profile of SKLB1028 [Срок оценки: Days 8, 15, 18, and 21 for remission induction and Days 8, and 21 for consolidation and Days 1 for maintenance]
• CR rate after the induction therapy [Срок оценки: up to 3months]
• Duration of remission [Срок оценки: up to 24months]
• Overall Survival [Срок оценки: up to 60months]
• Event-Free Survival [Срок оценки: up to 24months]
• Leukemia-free survival [Срок оценки: up to 24months]
• Rate of hematopoietic stem cell transplantation [Срок оценки: up to 12months]

Критерии участия

Критерии включения

• Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) > 20% blasts in the bone marrow according to WHO classification (2016) documented prior to enrollment.;
• Age ≥ 18 and < 60 years;
• Subjects who are positive for FLT3 mutations by central laboratory;
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• Subject must meet the following criteria as indicated on the clinical laboratory tests;

• Serum aspartate aminotransf
• Total serum bilirubin ≤ 2.5 x institutional ULN
• Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of > 30 ml/min
• Subject is suitable for oral administration of study drug.

Критерии исключения

• Confirmed diagnosis of acute promyelocytic leukemia (M3 /APL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia);
• Diagnosis of active malignancy other than AML;
• AML secondary to radiotherapy or chemotherapy for other tumors;
• AML with central nervous system involvement;
• Refractory hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and that occurs repeatedly in the past;
• Current clinically significant graft-ve
• Previous history of other malignancies.
• Patients with clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and von Willebrand disease;
• Major surgery of major organs has been performed before entering the study (for the definition of major surgery, refer to Grade 3 and 4 surgery specified in Management Measures for Clinical Application of Medical Technology, or the patient has not yet fully recovered from
• Subject has received prior therapy for AML with the following exceptions: a. emergency leukapheresis; b. emergency treatment with hydroxyurea ;c. growth factor or cytokine support; d. steroid for anaphylaxis or transfusion reaction;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT05445154 · HA114-CSP-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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