Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01161550
Status:
COMPLETED
Last Update Posted:
2013-07-23
First Post:
2010-07-09
Brief Title:
Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in RelapsedRefractory AML
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Phase 1 Study of Cladribine Based Induction Therapy CLAG With ATRA All-Trans Retinoic Acid and Midostaurin in RelapsedRefractory AML
Status:
COMPLETED
Status Verified Date:
2013-07
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:
CLAG ATRA AML
Brief Summary:
This study will evaluate the investigational drug Midostaurin in various doses given with ATRA and CLAG chemotherapy Midostaurin is a FLT3 inhibitor that is activated or overexpressed in a significant proportion of AML patients Research has shown that midostaurin and drugs like midostaurin may work better in combination with chemotherapy like CLAG CLAG is a combination of cladribine cytarabine and G-CSF which is approved by the FDA and used to treat AML
Detailed Description:
The main purpose of this study is to gather information about the use of a drug called midostaurin when given with ATRA and CLAG chemotherapy Midostaurin is an investigational drug It is a drug that inhibits FLT3 that is mutated or overexpressed in a significant proportion of AML patients Research has shown that midostaurin and drugs like midostaurin may work better in combination with chemotherapy like CLAG ATRA is known to promote myeloid differentiation and has also been shown to augment cancer cell death in combination with chemotherapy CLAG is a combination of cladribine cytarabine and G-CSF which is approved by the FDA and used to treat AML This study will look at how safe this combination is how you tolerate the treatment and to see what dose of midostaurin is appropriate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None