Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05330377
Status:
WITHDRAWN
Last Update Posted:
2023-04-25
First Post:
2022-04-08
Brief Title:
GM-CLAG in RelapsedRefractory FLT3-mutated AML
Sponsor:
Ayman H Qasrawi
Organization:
University of Kentucky
Study Overview
Official Title:
Phase Ib Trial of Gilteritinib in Combination With Mitoxantrone Cladribine Cytarabine and Filgrastim GM-CLAG for RelapsedRefractory FLT3-mutated Acute Myeloid Leukemia
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor withdrew funding
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 evaluate the dose-limiting toxicities DLT and define the maximum tolerated dose MTD and the recommended phase II study dose of gilteritinib when combined with mitoxantrone cladribine cytarabine and filgrastim GM-CLAG in participants with FLT3- mutated relapsed or refractory RR acute myeloid leukemia AML
Detailed Description:
The treatment of FLT3- mutated relapsed or refractory RR is challenging Gilteritinib as a single agent is the first FLT3 inhibitor to be FDA approved in the RR setting This phase I clinical trial will evaluate DLTMTD and the recommended phase II study dose of gilteritinib when combined with mitoxantrone cladribine cytarabine and filgrastim CLAG-M in patients with FLT3- mutated RR AML This study will also evaluate the pharmacodynamics and pharmacokinetics of gilteritinib when combined with CLAG-M at specific time points Although this combination has not been established to have superior clinical benefit in comparison to single-agent gilteritinib the objective of this trial is to provide a possible therapeutic benefit in addition to safety and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None