NCT04716114View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

March 24, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Acute Myeloid Leukemia (AML)
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

West China hospital of Sichuan University, Chengdu

All Listed Sponsors
lead

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY