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| ID | Type | Description | Link |
|---|---|---|---|
| AMC-UUCM-2004-0029 |
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RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening.
PURPOSE: This clinical trial is studying the side effects and how well donor stem cell transplant works when given after conditioning therapy in treating patients with hematologic cancer, recurrent or metastatic solid tumor, or other disease.
OBJECTIVES:
OUTLINE:
After the transplant, patients are followed periodically.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | |||
| busulfan | Drug | |||
| cyclosporine | Drug | |||
| fludarabine phosphate | Drug | |||
| methotrexate | Drug | |||
| methylprednisolone | Drug | |||
| allogeneic hematopoietic stem cell transplantation | Procedure | |||
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment (neutrophil, platelet, and red blood cells) | ||
| Frequency and kinetics of mixed chimerism as assessed by polymerase chain reaction | ||
| Frequency and severity of regimen-related toxicities | ||
| Frequency of acute and chronic graft-versus-host disease | ||
| Immune reconstitution |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate | ||
| Duration of tumor response | ||
| Survival |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
High-risk acute leukemia, including any of the following:
Chronic myelogenous leukemia in second chronic, accelerated, or blastic phase
Severe aplastic anemia that is not responsive to immunosuppressive therapy
Myelodysplastic syndromes, including any of the following:
Refractory or relapsed non-Hodgkin or Hodgkin lymphoma
Multiple myeloma
Biopsy proven measurable solid tumor meeting 1 of the following criteria:
Must have a related HLA-haploidentical mismatched (3/6 or fewer loci) donor available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoo H. Lee, MD | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center - University of Ulsan College of Medicine | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21715313 | Result | Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28. |
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| peripheral blood stem cell transplantation |
| Procedure |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D009369 | Neoplasms |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D002051 | Burkitt Lymphoma |
| D000741 | Anemia, Aplastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000013 | Congenital Abnormalities |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D000753 | Anemia, Refractory |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D006689 | Hodgkin Disease |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D008258 | Waldenstrom Macroglobulinemia |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |
| D016393 | Lymphoma, B-Cell |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D016399 | Lymphoma, T-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D000740 | Anemia |
| D000080983 | Bone Marrow Failure Disorders |
| D007945 | Leukemia, Lymphoid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009196 | Myeloproliferative Disorders |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D000072281 | Lymphadenopathy |
| D015448 | Leukemia, B-Cell |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D002066 | Busulfan |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D008727 | Methotrexate |
| D008775 | Methylprednisolone |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| 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 |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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