NCT04716114

A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated

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）

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	SKLB1028	SKLB1028 will be administered by oral capsules, 150 mg twice daily (BID).
DRUG	Salvage Chemotherapy	Low-dose cytarabine (LoDAC); azacytidine; homoharringtonine (HHT), cytarabine and aclarubicin (HAA) or fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) will be administered by subcutaneous (SC) and/or intravenous (IV) injections.

Timeline

• Start date: 2021-03-24
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-01-20
• Last updated: 2021-11-02

Locations

1 site across 1 country: China