NCT05445154RecruitingPhase 1/2
SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
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)
Source: ClinicalTrials.gov · Last updated 6 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 4 Jun 2021
- Start date
- 31 Aug 2021
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05445154
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 58
- From 31 Aug 2021 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- AML secondary to radiotherapy or chemotherapy for other tumors;
- 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;
Other illness
- Diagnosis of active malignancy other than AML;
- 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;
Other
- Confirmed diagnosis of acute promyelocytic leukemia (M3 /APL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia);
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.