Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Sorafenib Maintenance Therapy for Patients With FLT3-ITD AML After Allogeneic Stem Cell Transplantation|
- Maximum Tolerated Dose [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]To define the maximum tolerated dose (MTD) of maintenance sorafenib after allogeneic HSCT
- Median number of days sorafenib tolerated [ Time Frame: 3 years ] [ Designated as safety issue: No ]Define the median number of days of sorafenib tolerated prior to dose-limiting toxicity or disease relapse
- Rate of serious infections [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Rate of serious infections (bacterial, viral, fungal, or other) after starting sorafenib
- Rate of acute GVHD [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Rate of grades II-IV acute graft-vs-host disease (GVHD) after starting sorafenib
- Rate of chronic GVHD [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Rates of significant chronic GVHD after starting sorafenib
- Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]1-year and 2-year progression-free and overall survival after HSCT
- Impact of sorafenib on bone marrow and serum levels of FLT3-ITD quantitative PCR [ Time Frame: 3 years ] [ Designated as safety issue: No ]To assess the impact of sorafenib on quantitative bone marrow and serum levels of FLT3-ITD DNA in patients (as measured by PCR) with FLT3-ITD AML after allogeneic SCT
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Post-SCT Sorafenib
Sorafenib will be given as maintenance therapy after allo HCT to patients with FLT3-ITD AML.
Oral, 200 to 400 mg QD or BID
Other Name: BAY 43-9006
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398501
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||Yi-Bin Chen, MD||Massachusetts General Hospital|