Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01398501
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2011-07-19
Brief Title:
Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase I Trial of Sorafenib Maintenance Therapy for Patients With FLT3-ITD AML After Allogeneic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Sorfenib works by slowing the spread of cancer cells It has been used in other studies for patients with AML with the FLT3-ITD mutation and information from these studies suggests that sorafenib may help to control leukemia The purpose of this study is to find the highest dose of sorafenib for maintenance therapy that can be safely used in participants with AML who have undergone allogeneic stem cell transplant
Detailed Description:
Subjects will taken sorafenib orally either once or twice daily Subjects will come to the Bone Marrow Transplant Clinic 3 times on Day 8 15 and 30 during the first month of treatment After the first month they will be seen every month for 3 months and then at 9 at 6 and 9 months Subjects will have a physical exam and be asked questions regarding general health and specific questions about any problems they might be having and any medications they are taking
Subjects will have standard blood tests every month for 12 months to check liver and kidney function and complete blood count
Subjects will have research blood tests on Days 8 15 and 30 during the first month of treatment
Subjects will have a bone marrow biopsy after 3 months and 12 months of treatment
Subjects will receive treatment for up to 12 months and be followed for 1 year after completing the study
Subjects will have standard blood tests every month for 12 months to check liver and kidney function and complete blood count
Subjects will have research blood tests on Days 8 15 and 30 during the first month of treatment
Subjects will have a bone marrow biopsy after 3 months and 12 months of treatment
Subjects will receive treatment for up to 12 months and be followed for 1 year after completing the study
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