A Phase 3, Open-Label, Multicenter, Randomized Study of SKLB1028 Versus Salvage Chemotherapy in Patients With FLT3-mutated Acute Myeloid Leukemia Refractory to or Relapsed After First-line Treatment(ALIVE)
This is a randomized,multicenter, open-label Phase III, clinical study to confirm the efficacy and safety of SKLB1028 in patients with relapsed or refractory(R/R) FLT3-Mutated Acute Myeloid Leukemia(AML)compared to salvage chemotherapy.
• Patients volunteered to participate in this study and signed the informed consent form.
• Age≥18 years old, no gender limitation.
• Patient has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) as determined by pathological and morphological results, according to World Health Organization (WHO) 2016 classification.
• Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).
∙ Refractory to first-line AML treatment is defined as: the patient did not achieve complete remission/complete remission with incomplete hematologic recovery/complete remission with incomplete platelet recovery (CR/CRi/CRp) under initial therapy. A patient eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction therapy in the standard dose for the selected induction regimen. A patient not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this patient as per investigator's assessment.
‣ Early relapse after first-line AML therapy is defined as: the patients achieved CR/CRi/CRp after first-line treatment, and relapsed within 6 months with hematological relapse.
‣ Advanced relapse after first-line AML therapy is defined as: the patients achieved CR/CRi/CRp after first-line treatment and relapsed after 6 months with hematological relapse;
• Patient is positive for FLT3 mutation in bone marrow or whole blood.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patient is eligible for pre-selected salvage chemotherapy according to investigator assessment.
• Patient must meet the following criteria as indicated on the clinical laboratory tests:
∙ Serum aspartate aminotransferase and alanine aminotransferase ≤ 3.0 x upper limit of normal (ULN);
‣ Serum total bilirubin ≤ 1.5 x ULN;
‣ Serum creatinine ≤ 3.0 x ULN or an estimated glomerular filtration rate of \> 30 mL/min.
• Patient is suitable for oral administration of the study drug.
⁃ Female or male patient of childbearing age agree to take effective non-drug contraception from the date of signing an informed consent to 180 days after the last dose and will not donate sperm or eggs.