SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

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 .

Trial Details

NCT ID
NCT05445154
Phase
PHASE1 / PHASE2
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • SKLB1028 Dose Escalation
Locations (sample)
  • Chengdu, China|30.66667,104.06667

Key Eligibility Criteria

  • Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) \> 20% blasts in the bone marrow according to WHO classificati…
  • 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;

For full eligibility, visit ClinicalTrials.gov.

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