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| ID | Type | Description | Link |
|---|---|---|---|
| AMC-UUCM-2008-0037 |
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| Name | Class |
|---|---|
| Pusan National University Hospital | OTHER |
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RATIONALE: Giving low doses of chemotherapy and antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer and abnormal cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after busulfan, fludarabine, and antithymocyte globulin in treating patients with hematologic cancer or myelodysplastic syndrome.
OBJECTIVES:
OUTLINE: Before receiving the reduced-intensity conditioning regimen, patients receive one dose of intrathecal (IT) methotrexate, then leucovorin calcium IV or orally 4 hours after methotrexate and every 6 hours for a total of 8 doses.
NOTE: *Cyclosporine can be given orally once oral medication can be tolerated
After completion of study treatment, patients are followed periodically for up to 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure | administration of conditioning therapy including immunosuppressive agents plus alkylating agents and infusing hematopoietic progenitor cells collected from the donor | ||
| peripheral blood stem cell transplantation | Procedure | infusion of donor hematopoietic cells collected by leukapheresis after mobilization with growth factor |
| Measure | Description | Time Frame |
|---|---|---|
| tumor response | leukemia CR, CR duration | about 4-8 weeks after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Donor cell engraftment (neutrophil, platelet, and red blood cells) | neutrophi count over 500/ul | 10-35 days after transplantation |
| Acute and chronic graft-versus-host disease | ocurrence of acute or chronic GVHD |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematological malignancies:
Acute leukemia, including any of the following:
Chronic myelogenous leukemia (CML)
Myelodysplastic syndrome (MDS)
No willing, suitable HLA-matched donor in family or in donor registries
Related donor with HLA-haploidentical mismatch at 3 or less of 6 loci available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoo H. Lee, MD | Asan Medical Center | Principal Investigator |
| 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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| 15-100 days; 100 days to 4 years |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D015456 | Leukemia, Biphenotypic, Acute |
| D001752 | Blast Crisis |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
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| ID | Term |
|---|---|
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| 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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