A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

June 15, 2023

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2027

Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation
Interventions
DRUG

XY0206

Dosage form:Tablet;Multiple dose phase:Take the medicine once a day,37.5mg at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until the subjects meet the withdrawal criteria.

DRUG

Salvage Chemotherapy

Low-dose Cytarabine (LoDAC) or azacitidine, fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) or mitoxantrone, etoposide, cytarabine (MEC)will be administered by subcutaneous (SC) and/or intravenous (IV) injections.

All Listed Sponsors
lead

Shijiazhuang Yiling Pharmaceutical Co. Ltd

INDUSTRY

NCT05876832 - A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE) | Biotech Hunter | Biotech Hunter