Combining SKLB1028 with standard chemotherapy for newly diagnosed acute myeloid leukemia

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)

This study is testing if adding a new drug called SKLB1028 to standard chemotherapy helps people with newly diagnosed acute myeloid leukemia feel better and manage side effects.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chengdu)
• Trial ID: NCT05445154 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of SKLB1028 when used alongside cytarabine and daunorubicin in patients with newly diagnosed acute myeloid leukemia (AML). It aims to identify dose-limiting toxicities and characterize the pharmacokinetics of SKLB1028 during remission induction and consolidation therapy. The study follows a 7+3 treatment schedule, which is a standard approach for AML treatment. Participants will be closely monitored for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with untreated de novo AML and positive FLT3 mutations.

Not a fit: Patients with acute promyelocytic leukemia or other active malignancies will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve remission rates and overall outcomes for patients with newly diagnosed AML.

How similar studies have performed: Other studies have shown promise in combining novel agents with standard chemotherapy for AML, suggesting potential for success in this approach.

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;

Where this trial is running

Chengdu

• West China Hospital of Sichuan University — Chengdu, China (Recruiting)

Study contacts

• Study coordinator: Liu Ting, Chief doctor

Conditions Newly Diagnosed Acute Myeloid Leukemia