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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-4189 | Other Identifier | University of South Florida IRB | |
| NCI-G00-1755 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
OBJECTIVES:
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the beginning of the study. If CNS involvement is documented, patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses. Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant. Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant.
Patients are followed once a week for 3 months, and then monthly for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cy/TBI | Other | cyclophosphamide and total body irradiation (TBI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5) |
|
| Measure | Description | Time Frame |
|---|---|---|
| event free survival (EFS) | EFS determined by the Kaplan-Meier product limit method | five year post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of graft versus host disease | incidence and severity of acute and chronic GVHD | five years post transplant |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
Acute lymphocytic leukemia (ALL):
Acute myelogenous leukemia (AML):
Chronic myelogenous leukemia (CML):
Chronic lymphocytic leukemia (CLL):
Multiple myeloma:
Myelodysplasia - all subtypes
Myeloproliferative disorders - patients with poor response to medical therapy or cytogenetic abnormalities
Severe aplastic anemia (SAA):
Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Field, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612-9497 | United States |
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| TBI | Radiation | FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy. |
|
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015470 | Leukemia, Myeloid, Acute |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D011087 | Polycythemia Vera |
| D055728 | Primary Myelofibrosis |
| D013920 | Thrombocythemia, Essential |
| D000753 | Anemia, Refractory |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D008206 | Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007951 | Leukemia, Myeloid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D000740 | Anemia |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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