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

Launched by CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY CO., LTD. · Jun 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults who have been recently diagnosed with acute myeloid leukemia (AML), a type of cancer affecting the blood and bone marrow. The trial is focused on a medication called SKLB1028, which is being tested alongside two other drugs, daunorubicin and cytarabine, to see how well they work together and to find out any side effects. Researchers want to understand how safe this combination is and how the body processes the new drug, especially during the initial treatment and follow-up stages.

To participate in this trial, individuals need to be between 18 and 60 years old and have a confirmed diagnosis of untreated AML with specific characteristics (like certain genetic mutations). They should also be in relatively good health, as indicated by their ability to carry out daily activities. Participants can expect to receive close medical supervision throughout the trial, including monitoring for any side effects from the treatment. This study is currently recruiting, so it’s a good opportunity for eligible patients to explore new treatment options for their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.;
• • 2. Age ≥ 18 and \< 60 years;
• • 3. Subjects who are positive for FLT3 mutations by central laboratory;
• • 4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• • 5. Subject must meet the following criteria as indicated on the clinical laboratory tests;
• • 1. Serum aspartate aminotransf
• • 2. Total serum bilirubin ≤ 2.5 x institutional ULN
• • 3. Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of \> 30 ml/min
• • 6. Subject is suitable for oral administration of study drug.
• Exclusion Criteria:
• • 1. Confirmed diagnosis of acute promyelocytic leukemia (M3 /APL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia);
• • 2. Diagnosis of active malignancy other than AML;
• • 3. AML secondary to radiotherapy or chemotherapy for other tumors;
• • 4. AML with central nervous system involvement;
• • 5. Refractory hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and that occurs repeatedly in the past;
• • 6. Current clinically significant graft-ve
• • 7. Previous history of other malignancies.
• • 8. Patients with clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and von Willebrand disease;
• • 9. 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
• • 10. 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;