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| ID | Type | Description | Link |
|---|---|---|---|
| ECOG-E1903 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive a preparative regimen comprising total-body irradiation twice on day -8; fludarabine IV over 30 minutes on days -7 to -3; thiotepa IV over 2 hours twice on day -7; and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo haploidentical allogeneic peripheral blood stem cell transplantation on day 0.
Patients are followed at day 100, at least monthly for 2 years, and then periodically for 3 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2.2 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Drug | |||
| fludarabine phosphate | Drug | |||
| thiotepa | Drug | |||
| biological therapy | Procedure | |||
| bone marrow ablation with stem cell support | Procedure | |||
| chemotherapy | Procedure | |||
| non-specific immune-modulator therapy | Procedure |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Mark R. Litzow, MD | Mayo Clinic | Study Chair |
| Jacob M. Rowe, MD | Rambam Health Care Campus |
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| peripheral blood stem cell transplantation | Procedure |
| radiation therapy | Procedure |
| ID | Term |
|---|---|
| D004915 | Leukemia, Erythroblastic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| D007947 | Leukemia, Megakaryoblastic, Acute |
| D000013 | Congenital Abnormalities |
| D015479 | Leukemia, Myelomonocytic, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| C042382 | fludarabine phosphate |
| D013852 | Thiotepa |
| D001691 | Biological Therapy |
| D004358 | Drug Therapy |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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