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

NCT05445154 | Recruiting Phase 1

• 1 other identifier: HA114-CSP-007
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Newly Diagnosed Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (1)

• Number of participants with dose limiting toxicities (DLTs)

  A DLT is defined as any Grade ≥ 3 non-hematologic or extramedullary toxicity that occur during the DLT assessment period, and that is considered to be possibly, probably, or definitely related to onsolidation therapies including the study drugs.

  up to Day42

Secondary Outcomes (7)

• Pharmacokinetics profile of SKLB1028

  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

  up to 3months

• Duration of remission

  up to 24months

• Overall Survival

  up to 60months

• Event-Free Survival

  up to 24months

Study Arms (1)

SKLB1028 Dose Escalation

EXPERIMENTAL

Part1:Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and the experimental drug SKLB1028.SKLB1028 capsules beginning at 100 mg bid. Part2: Once the appropriate therapeutic schedule has been established in Part 1, up to 20 subjects will be enrolled into an expansion cohort.

Drug: SKLB1028 Dose Escalation

Interventions

SKLB1028 Dose Escalation DRUG

Drug :SKLB1028 ;Drug: Cytarabine ;Drug: Daunorubicin

SKLB1028 Dose Escalation

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, China

RECRUITING

Central Study Contacts

Liu Ting, Chief doctor

CONTACT

+8618980601240; liuting@scu.edu.cn

Wang Jianxiang, Chief doctor

CONTACT

wangjx@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: July 6, 2022
• Study Start: August 31, 2021
• Primary Completion: October 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 6, 2022

Record last verified: 2022-05

Locations

CN (1)