A Phase 1 interventional study of Sorafenib in Acute Myeloid Leukemia, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-22.
Sponsored by Massachusetts General Hospital · Phase 1, Interventional, and Treatment
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.
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.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sorafenib will be given as maintenance therapy after allo HCT to patients with FLT3-ITD AML.
Drug: Sorafenib
Oral, 200 to 400 mg QD or BID
Also known as: BAY 43-9006
Maximum Tolerated Dose
To define the maximum tolerated dose (MTD) of maintenance sorafenib after allogeneic HSCT
Time frame: 3 years
Median number of days sorafenib tolerated
Define the median number of days of sorafenib tolerated prior to dose-limiting toxicity or disease relapse
Time frame: 3 years
Rate of serious infections
Rate of serious infections (bacterial, viral, fungal, or other) after starting sorafenib
Time frame: 3 years
Rate of acute GVHD
Rate of grades II-IV acute graft-vs-host disease (GVHD) after starting sorafenib
Time frame: 3 years
Rate of chronic GVHD
Rates of significant chronic GVHD after starting sorafenib
Time frame: 3 years
Survival
1-year and 2-year progression-free and overall survival after HSCT
Time frame: 3 years
Impact of sorafenib on bone marrow and serum levels of FLT3-ITD quantitative PCR
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
Time frame: 3 years
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital