NCT05876832

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

Phase 3 Open-label, Multicenter, Randomized Study of XY0206 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3(FLT3)-Internal Tandem Duplication（ITD） Mutation

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the clinical benefit of XY0206 therapy in participants with FLT3-ITD mutated AML who are refractory to or have relapsed after prior AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study is also to investigate the efficacy of XY0206 as assessed by CR/CRh rate in these subjects。

Detailed description

Participants considered an adult according to local regulations at the time of signing informed consent will be randomized in a 2:1 ratio to receive XY0206 or salvage chemotherapy. Participants will enter the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator will preselect a salvage chemotherapy regimen for each participant; options will include low-dose cytarabine (LoDAC),azacitidine, fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) or mitoxantrone, etoposide and cytarabine (MEC) . The randomization will be stratified by remission from previous treatment and preselected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles. Participants who have a donor identified and with complete remission after treatment may undergo hematopoietic stem cell transplant (HSCT) without leaving the study. After treatment discontinuation, participants will have a end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety. After that, long term follow-up will be done every 90 days.

Conditions

• Acute Myeloid Leukemia With FLT3/ITD Mutation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-15
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2023-05-25
• Last updated: 2023-05-26