Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265545
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-01-17
Brief Title:
Multicenter Platform-type Clinical Study of RefractoryRecurrent Acute Myeloid Leukemia
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
Multicenter Platform-type Clinical Study of RefractoryRecurrent Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-04
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:
To study the optimal therapeutic strategies for salvage treatment of refractoryrelapsed AML and to clarify the effectiveness and safety of various salvage treatment options A prospective multicenter platform-type study was conducted to explore the overall response rate tolerability and survival of patients with RR AML with different treatment regimens
Detailed Description:
It is recommended to routinely screen for chromosomal karyotype FLT3ITD FLT3TKD and IDH1 mutations before enrollmentAccording to the patients condition and physical condition evaluate whether there is a suitable new drug clinical trial to enroll if there is enter the Arm 7 new drug clinical trial If not enter other arm of the clinical studyAccording to the results of gene mutation patients with target gene mutations should enter the corresponding study cohort Arm1 Arm2 and select the regimen of specific targeted drug composition For patients without a target mutation patients eligible for intensive chemotherapy who had not received Venetoclax in the last 3 months were randomized to the Daunorubicinidarbicinmitoxantrone combination cytarabine VenetoclaxDAV Arm3 and the Hyperhardinine combination cytarabine Venetoclax cohort HAV Arm4 Patients who were intolerant to intense chemotherapy were enrolled in the Venetoclax combined with Azacitidine cohort Arm5 For patients who have failed treatment with Venetoclax within the last 3 months the Venetoclax-based regimen is not recommended again and the physician is advised to conduct an exploratory trial Arm6 After CR form induction therapy allogeneic hematopoietic stem cell transplantation should be selected as far as possible according to the patients wishes For patients who are unable or unwilling to undergo allogeneic hematopoietic stem cell transplantation physicians may choose post-remission consolidation therapy based on experience
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