Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
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.
Eligible subjects will be randomized in a 2:1 ratio to receive SKLB1028 or salvage chemotherapy. Subjects will enter the screening period up to 14 days before the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subject. Options will include low-dose cytarabine (LoDAC), azacitidine, homoharringtonine (HHT), cytarabine and aclarubicin (HAA) or fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). The randomization will be stratified by indications and intensity of pre-selected salvage chemotherapy. Subjects will be orally administrated SKLB1028 twice daily over continuous 28-day cycles . Subjects in the salvage chemotherapy group will receive chemotherapy as required by the guidelines. Subjects receiving SKLB1028, LoDAC, or azacytidine will continue to receive the treatment until a treatment discontinuation criterion is met. Subjects receiving HAA or FLAG will take 1 cycle of therapy and will be assessed for response after the 1st cycle. After the efficacy evaluation, the subject may receive a second cycle of chemotherapy at the investigator's discretion. will receive the second cycle of chemotherapy. Subjects who have a donor identified and with complete remission after treatment may undergo hematopoietic stem cell transplant (HSCT) without leaving the study. Subjects in the salvage chemotherapy group who withdrew due to non-response to treatment or disease progression, could switch to SKLB1028 if SKLB1028 will likely benefit the patient at the investigator's discretion. ;
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