Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03170895
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2017-05-26
Brief Title:
Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or RelapsedRefractory AML Carrying FLT3-ITD
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
A Phase II Single-arm Open-labeled Study Evaluating Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or RelapsedRefractory AML Carrying FLT3-ITD
Status:
COMPLETED
Status Verified Date:
2020-03
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:
The study aims to test if combination of sorafenib and omacetaxine mepesuccinate OM also known as homoharringtonine results in durable composite complete remission CRc in patients with newly diagnosed or relapsedrefractory RR acute myeloid leukemia AML carrying FLT3-ITD Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication
Detailed Description:
The type of AML being studied in this clinical trial is known as FMS-like tyrosine kinase 3 FLT3-internal tandem duplication ITD positive AML This type of AML has an alteration or mutation in genes which may associated with high risk of relapse after conventional chemotherapy and hence an extremely poor clinical outcome
FLT3 inhibitors including sorafenib are effective in inducing remission However their effects are only transient There is an unmet clinic need to enhance their effectiveness hence clinical application
This is a Phase II single-arm open-labeled study A total of 40 eligible patients with consent will be recruited including 20 patients with newly diagnosed and 20 with RR FLT3-ITD AML
For newly diagnosed patients diagnostic bone marrow BM andor peripheral blood PB will be evaluated by next generation sequencing NGS based on myeloid panel that comprises 54 myeloid genes as well as their in vitro response to sorafenib and omacetaxine mepesuccinate OM based on an in-house platform that was established in our laboratory FLT3-ITD allelic burden will also be evaluated
For RR patients FLT3-ITD status and allelic burden will be confirmed before treatment Both groups of patients will receive sorafenib 400 mg twice daily continuously and OM 15 mgm2 daily for 7 days every 28 days until progression or allogeneic hematopoietic stem cell transplantation HSCT Thereafter patients will be followed up and information about disease status and survival will be collected BM examination will be performed on day 28 to document morphological response and FLT3-ITD allelic burden
At leukemia progression BM andor PB samples will be collected and their in vitro response to sorafenib and OM examined The tyrosine kinase domain TKD of FLT3 will also be sequenced and FLT3-ITD allelic burden will be evaluated
FLT3 inhibitors including sorafenib are effective in inducing remission However their effects are only transient There is an unmet clinic need to enhance their effectiveness hence clinical application
This is a Phase II single-arm open-labeled study A total of 40 eligible patients with consent will be recruited including 20 patients with newly diagnosed and 20 with RR FLT3-ITD AML
For newly diagnosed patients diagnostic bone marrow BM andor peripheral blood PB will be evaluated by next generation sequencing NGS based on myeloid panel that comprises 54 myeloid genes as well as their in vitro response to sorafenib and omacetaxine mepesuccinate OM based on an in-house platform that was established in our laboratory FLT3-ITD allelic burden will also be evaluated
For RR patients FLT3-ITD status and allelic burden will be confirmed before treatment Both groups of patients will receive sorafenib 400 mg twice daily continuously and OM 15 mgm2 daily for 7 days every 28 days until progression or allogeneic hematopoietic stem cell transplantation HSCT Thereafter patients will be followed up and information about disease status and survival will be collected BM examination will be performed on day 28 to document morphological response and FLT3-ITD allelic burden
At leukemia progression BM andor PB samples will be collected and their in vitro response to sorafenib and OM examined The tyrosine kinase domain TKD of FLT3 will also be sequenced and FLT3-ITD allelic burden will be evaluated
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