SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SKLB1028 Dose Escalation.
- Who it may be relevant to
- Registry conditions: Newly Diagnosed Acute Myeloid Leukemia (AML). Basic parameters: 18 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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 .
Interventions
- Drug SKLB1028 Dose Escalation
Drug :SKLB1028 ;Drug: Cytarabine ;Drug: Daunorubicin
Primary outcome measures
- Number of participants with dose limiting toxicities (DLTs) [Time frame: up to Day42]
Secondary outcome measures (7)
- Pharmacokinetics profile of SKLB1028 [Time frame: 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 [Time frame: up to 3months]
- Duration of remission [Time frame: up to 24months]
- Overall Survival [Time frame: up to 60months]
- Event-Free Survival [Time frame: up to 24months]
- Leukemia-free survival [Time frame: up to 24months]
- Rate of hematopoietic stem cell transplantation [Time frame: up to 12months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT05445154 · HA114-CSP-007