Combining SKLB1028 with standard chemotherapy for newly diagnosed acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of SKLB1028 when used alongside cytarabine and daunorubicin in patients with newly diagnosed acute myeloid leukemia (AML). It aims to identify dose-limiting toxicities and characterize the pharmacokinetics of SKLB1028 during remission induction and consolidation therapy. The study follows a 7+3 treatment schedule, which is a standard approach for AML treatment. Participants will be closely monitored for their response to the treatment and any adverse effects.

Why it matters

Who can join: the full rules

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;

Where it's running

• West China Hospital of Sichuan University
  Chengdu, China Recruiting

Study contacts

• Study coordinator: Liu Ting, Chief doctor
• Email: liuting@scu.edu.cn
• Phone: +8618980601240

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venetoclax with azacitidine, chidamide and CAG chemotherapy for fit older adults with AML

  This will test whether adding venetoclax and chidamide to azacitidine plus CAG chemotherapy helps people aged 60-75 with newly diagnosed AML achieve remission more often than the standard 3+7 regimen.

  Recruiting Phase 3 Chinese PLA General Hospital · Beijing, None Selected · NCT07514936

• Alternating venetoclax+azacitidine and low-dose cladribine+homoharringtonine+cytarabine for unfit newly diagnosed AML

  This phase II trial tests whether alternating venetoclax + azacitidine with low-dose cladribine + homoharringtonine + cytarabine can help people aged ≥60 or otherwise unfit with newly diagnosed AML become MRD negative and achieve better disease control.

  Recruiting at 5 sites Phase 2 First Affiliated Hospital of Zhejiang University · Beijing, Beijing Municipality and 4 other locations · NCT07172204

• Investigating APL-4098 with Azacitidine for treating relapsed or refractory AML and high-risk MDS

  This study is testing a new treatment called APL-4098, alone and with azacitidine, to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia and high-risk myelodysplastic syndrome.

  Recruiting at 8 sites Phase 1 Apollo Therapeutics Ltd · Clayton, Victoria and 8 other locations · NCT06372717

• Comparing HVA regimen to standard chemotherapy for high-risk acute myeloid leukemia

  This study is testing a new treatment combining homohartonine with venetoclax and azacitidine to see if it works better than standard chemotherapy for people with high-risk acute myeloid leukemia.

  Recruiting Phase 3 Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT06810791

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.