Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03690115
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2018-04-04
Brief Title:
Study of Ponatinib Iclusig for Prevention of Relapse After Allogeneic Stem Cell Transplantation Allo-SCT in FLT3-ITD AML Patients
Sponsor:
Versailles Hospital
Organization:
Versailles Hospital
Study Overview
Official Title:
Phase 2 Study of Ponatinib Iclusig for Prevention of Relapse After Allogeneic Stem Cell Transplantation Allo-SCT in FLT3-ITD AML Patients the PONALLO Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
PONALLO
Brief Summary:
Recent advances in acute myeloid leukemia AML have been characterized by a better understanding of disease biology As such FMS-like tyrosine kinase 3-internal tandem duplication FLT3-ITD have been recognized as conferring a poor prognosis The FLT3-ITD molecular mutation is observed in about one-quarter of patients diagnosed with AML Patients presenting with this abnormality are referred for early allogeneic stem-cell transplantation allo-SCT However some data suggest that FLT3-ITD remains associated with a poor prognosis even after allo-SCT because of higher risk of relapse and strategies for preventing relapse in the post-transplant setting are required Hu et al Expert Rev Hematol 2014 For example in a large cohort of patients Brunet et al JCO 2012 the incidence of relapse for FLT3-ITD AML patients after allo-SCT was 30 at 2-years significantly higher compared to FLT3-ITD negative patients p0006
Ponatinib Iclusig is an orally available tyrosine kinase inhibitor with a unique binding mechanism allowing inhibition of BCR-ABL kinases including those with the T315I point mutation Ponatinib also has in vitro inhibitory activity against a discrete set of kinases implicated in the pathogenesis of other hematologic malignancies including FLT3 KIT fibroblast growth factor receptor 1 FGFR1 and platelet derived growth factor receptor α PDGFRα In vitro activity of ponatinib in AML has been already demonstrated Gozgit et al Mol Cancer Ther 2011 Smith et al Blood 2013 If some trials are on-going to test ponatinib alone or in combination with chemotherapy in FLT3-ITD AML Clinicaltrialsgov no study is dedicated to the use of ponatinib in the post-transplant setting in order to prevent relapse in these patients
The main goal of this study will be to determine the maximal tolerated dose MDT of ponatinib after allo-SCT in FLT3-ITD AML patients then to investigate the efficacy of ponatinib in a larger cohort of patients
Ponatinib Iclusig is an orally available tyrosine kinase inhibitor with a unique binding mechanism allowing inhibition of BCR-ABL kinases including those with the T315I point mutation Ponatinib also has in vitro inhibitory activity against a discrete set of kinases implicated in the pathogenesis of other hematologic malignancies including FLT3 KIT fibroblast growth factor receptor 1 FGFR1 and platelet derived growth factor receptor α PDGFRα In vitro activity of ponatinib in AML has been already demonstrated Gozgit et al Mol Cancer Ther 2011 Smith et al Blood 2013 If some trials are on-going to test ponatinib alone or in combination with chemotherapy in FLT3-ITD AML Clinicaltrialsgov no study is dedicated to the use of ponatinib in the post-transplant setting in order to prevent relapse in these patients
The main goal of this study will be to determine the maximal tolerated dose MDT of ponatinib after allo-SCT in FLT3-ITD AML patients then to investigate the efficacy of ponatinib in a larger cohort of patients
Detailed Description:
None
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