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New treatment option for Newly Diagnosed Acute Myeloid Leukemia (AML)
Official title SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT05445154
What this study is testing
What is SKLB1028 Dose Escalation?
SKLB1028 Dose Escalation is an investigational medicine, being studied as a potential treatment for newly diagnosed acute myeloid leukemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59
You may be able to join if
- Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) \> 20% blasts in the bone marrow according to WHO classification...
- Age ≥ 18 and \< 60 years;
- people 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;
You likely can't join 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
See the full eligibility 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;
- people 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.