Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03642236
Status:
UNKNOWN
Last Update Posted:
2018-08-22
First Post:
2018-08-20
Brief Title:
Combination of BTK Inhibitor Overcomes Drug-resistance in RefractoryRelapsed FLT3 Mutant AML
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Combination of Brutons Tyrosine Kinase BTK Inhibitor Overcomes Drug-resistance in RefractoryRelapsed FLT3 Mutant Acute Myeloid Leukemia AML
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
ENROLLING_BY_INVITATION
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:
Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant AML BTK is reported to be a therapeutic target in this subtype leukemia Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitorschemotherapy in refractoryrelapsed FLT3 mutant AML In this prospective randomized controlled study the efficacy and safety of combination of BTK inhibitor with chemotherapy withwithout FLT3 inhibitor in refractoryrelapsed FLT3 mutant AML are evaluated
Detailed Description:
Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant acute myeloid leukemia AML How to overcome the resistance to FLT3 inhibitors or chemotherapy needs further study Brutons tyrosine kinase BTK is reported to be a therapeutic target in this subtype leukemia Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitorschemotherapy in refractoryrelapsed FLT3 mutant AML In this prospective randomized controlled study we are going to inhibit BTK with BTK inhibitor ibrutinib in the patients with refractoryrelapsed FLT3 mutant AML and then test the enhancing effect and safety of combination of ibrutinib with chemotherapy withwithout FLT3 inhibitor to make sure inhibition of BTK overcomes drug-resistance in FLT3 mutation AML
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