Shijiazhuang Y Iling pharmaceutical co. Ltd
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。
Acute Myeloid Leukemia With FLT3/ITD Mutation
XY0206
Salvage Chemotherapy
Phase 3
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 312 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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 |
Actual Study Start Date : | June 15, 2023 |
Estimated Primary Completion Date : | July 1, 2027 |
Estimated Study Completion Date : | July 1, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: XY0206 XY0206 will be administered orally once a day in continuous 28-day cycles. |
Drug: XY0206 |
Active Comparator: Salvage chemotherapy Participants will receive salvage chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) injection for 10 days. Participants on azacitidine will receive 75 mg/m^2 daily by SC or IV injection for 7 days.Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor (G-CSF) (FLAG) will receive 30 mg/m^2 of fludarabine daily by IV for 5 days (day 2 to 6), 1~2 g/m2 of cytarabine daily by IV for 5 days (day 2 to 6), and 300 μg/m^2 of G-CSF daily by SC or IV for 5 days (days 1 to 5). After completion of chemotherapy, G-CSF will be administered continually until absolute neutrophil count(ANC)>0.5 x 10^9 / L. Participants on mitoxantrone, etoposide, cytarabine(MEC) will receive 8 mg/m^2 of mitoxantrone daily by IV for 3 days (day 1 to 3), 100 mg/m2 of etoposide daily by IV for 7 days (day 1 to 7), and 100 mg/m^2 of cytarabine daily by IV for 7 days (days 1 to 7) |
Drug: Salvage Chemotherapy |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.