Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-05-17
Brief Title:
A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation ALIVE
Sponsor:
Shijiazhuang Yiling Pharmaceutical Co Ltd
Organization:
Shijiazhuang Yiling Pharmaceutical Co Ltd
Study Overview
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 3FLT3-Internal Tandem DuplicationITD Mutation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CRCRh 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 21 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 LoDACazacitidine 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None