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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-SCT Sorafenib | Experimental | Sorafenib will be given as maintenance therapy after allo HCT to patients with FLT3-ITD AML. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | Oral, 200 to 400 mg QD or BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | To define the maximum tolerated dose (MTD) of maintenance sorafenib after allogeneic HSCT | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median number of days sorafenib tolerated | Define the median number of days of sorafenib tolerated prior to dose-limiting toxicity or disease relapse | 3 years |
| Rate of serious infections | Rate of serious infections (bacterial, viral, fungal, or other) after starting sorafenib |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Bin Chen, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25239228 | Result | Chen YB, Li S, Lane AA, Connolly C, Del Rio C, Valles B, Curtis M, Ballen K, Cutler C, Dey BR, El-Jawahri A, Fathi AT, Ho VT, Joyce A, McAfee S, Rudek M, Rajkhowa T, Verselis S, Antin JH, Spitzer TR, Levis M, Soiffer R. Phase I trial of maintenance sorafenib after allogeneic hematopoietic stem cell transplantation for fms-like tyrosine kinase 3 internal tandem duplication acute myeloid leukemia. Biol Blood Marrow Transplant. 2014 Dec;20(12):2042-8. doi: 10.1016/j.bbmt.2014.09.007. Epub 2014 Sep 17. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| 3 years |
| Rate of acute GVHD | Rate of grades II-IV acute graft-vs-host disease (GVHD) after starting sorafenib | 3 years |
| Rate of chronic GVHD | Rates of significant chronic GVHD after starting sorafenib | 3 years |
| Survival | 1-year and 2-year progression-free and overall survival after HSCT | 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 | 3 years |
| Boston |
| Massachusetts |
| 02214 |
| United States |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |