NCT05445154 SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
| NCT ID | NCT05445154 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
| Condition | Newly Diagnosed Acute Myeloid Leukemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2021-08-31 |
| Primary Completion | 2024-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 58 participants in total. It began in 2021-08-31 with a primary completion date of 2024-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 .
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05445154 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Newly Diagnosed Acute Myeloid Leukemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05445154 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05445154 currently recruiting?
Yes, NCT05445154 is actively recruiting participants. Contact the research team at liuting@scu.edu.cn for enrollment information.
Where is the NCT05445154 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT05445154 clinical trial?
NCT05445154 is sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. The trial plans to enroll 58 participants.
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