Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05586074
Status:
RECRUITING
Last Update Posted:
2023-03-23
First Post:
2022-10-14
Brief Title:
HEC73543 Versus Salvage Chemotherapy in RR FLT3-ITD AML
Sponsor:
Sunshine Lake Pharma Co Ltd
Organization:
Sunshine Lake Pharma Co Ltd
Study Overview
Official Title:
HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia a Multicenter Open-label Randomized Phase 3 Trial
Status:
RECRUITING
Status Verified Date:
2022-10
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:
A randomizedmulticenter open-label Phase III clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed refractory RR FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy and also to investigate the efficacy of Clifutinib as assessed by CRCRh rate in these subjects
Detailed Description:
Subjects who are at least 18 years and above at the time of signing informed consent may participate in this study Subjects will be randomized in a 21 ratio to receive Clifutinib or salvage chemotherapy Subjects will enter the screening period up to 28 days prior to the start of treatment Prior to randomization a salvage chemotherapy regimen will be pre-selected for each subjects options will include low-dose cytarabine LoDAC azacitidine decitabine Ara-CIDA or FLAGIDA The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy Participants will be administered treatment over continuous 28-day cycles
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
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