Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02867891
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2016-08-10
Brief Title:
Sorafenib In Relapse of FMS-like Tyrosine Kinase 3 FLT3-Internal Tandem Duplication ITD AML Trial
Sponsor:
Robert Zeiser
Organization:
University of Freiburg
Study Overview
Official Title:
Multicenter Observational Trial to Determine the Response Rate of Sorafenib and Donor Lymphocyte Infusions DLI Versus Best Available Treatment BAT in FLT3-ITD-mutant AML Relapse After Allogeneic Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2017-01
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:
SIRA
Brief Summary:
In this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention The investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with FLT3-ITD AML relapse after allo-HSCT
Detailed Description:
The preliminary data of the investigators demonstrate potent activity of Sorafenib combined with Donor lymphocyte infusions DLI in relapse of FLT3-ITD Acute myeloid leukemia AML after allogeneic hematopoietic cell transplantation allo-HSCT The investigators therefore launched an observational multicenter trial The outcomes are assessed in 4 pre-defined groups of individuals according to the therapeutic intervention chemotherapy-alone-group chemotherapyDLI group sorafenib alone group and sorafenibDLI group The specific interventions to the subjects of the study are assigned by the individual transplant center The investigators will determine the outcome of each group by monitoring the survival and the response rates complete remission disease burden reduction no response of patients with FLT3-ITD AML relapse after allo-HSCT
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