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This is a Phase II study following subjects proceeding with Treosulfan (36g/m2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg/kg, tacrolimus and MMF for GVHD prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treo/Flu with PTCy | Experimental | Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treosulfan | Drug | 12 g/m2 administered intravenously over 2 hours on days -4, -3, and -2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Evaluate rates of overall survival at 100 days after transplant. | Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant Related Mortality | ● Estimate transplant related mortality (TRM) at 100 days and 1 year with this conditioning and GVHD prophylaxis combination | Day 100 and 1 year |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Graham, MD | Contact | 612-625-3051 | grah0329@umn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Fludarabine | Drug | Fludarabine will be administered intravenously over 1 hour, every 24 hours on days -6 to -2. The daily dose of fludarabine will be determined by model-based dosing utilizing Bayesian methodology . |
|
| Total Body Irradiation | Radiation | TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines. |
|
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| Tacrolimus | Drug | Tacrolimus may be initiated on day +5 either PO or IV gtt , with a goal trough level of 5-10mg/mL and avoiding higher levels for the first two weeks post-transplant, as recent evidence demonstrated increased adverse events for levels over 10 mg/mL. |
|
| Mycophenolate Mofetil | Drug | All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later. |
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| Cyclophosphamid | Drug | Cyclophosphamide 40 mg/kg will be given as an IV infusion over 1-2 hours (depending on volume) on Days +3 post-transplant (between 60 and 72 hours after stem cell infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). |
|
| Stem Cell Infusion | Biological | Given on day 0. |
|
Estimate overall survival at 1 and 2 years
| 1 and 2 years |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C018404 | treosulfan |
| C024352 | fludarabine |
| D014916 | Whole-Body Irradiation |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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