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| ID | Type | Description | Link |
|---|---|---|---|
| AMC-UUCM-2009-0579 |
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RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell 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 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 phase II trial is studying how well donor stem cell transplant or bone marrow transplant works in treating patients with acute myeloid leukemia in remission.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Conditioning chemotherapy and allogeneic bone marrow or hematopoietic stem cell transplantation (HSCT): After completion of induction chemotherapy and a resulting complete response (CR1) or salvage chemotherapy resulting in CR2, patients receive 1 of the following conditioning regimens and transplantations determined by age, co-morbidity, and type of available donor:
NOTE: *Significant co-morbidity is defined as residual fungal or other infections in the lung or other viscera and residual organ toxicities occurring during induction or consolidation chemotherapy.
After completion of study therapy, patients are followed every 3 months for 3 years and then annually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transplantation | Experimental | perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological |
| ||
| busulfan |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the treatment measured in terms of frequency of relapse and duration of remission | duration of CR, leukemia recurrence | up to 2 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment | achievement of neutrophil count over 500/ul | up to 35 days after transplantation |
| Acute and chronic graft-versus-host disease | up to 100 days for acute GVHD and up to 2 years for chronic GVHD |
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DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
No acute promyelocytic leukemia or acute myeloid leukemia with chromosomal changes t(8;21), inv 16, or t(15;17)
Must have a donor available meeting one of the following criteria:
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 |
|---|---|---|---|---|---|---|
| Inje University - Haeundae Paik Hospital | Busan | 612-030 | South Korea | |||
| Asan Medical Center - University of Ulsan College of Medicine |
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|
| cyclophosphamide | Drug |
|
| cyclosporine | Drug |
|
| fludarabine phosphate | Drug |
|
| methotrexate | Drug |
|
| allogeneic hematopoietic stem cell transplantation | Procedure |
|
| Treatment-related mortality | up to 2 years after transplantation |
| Leukemia-free survival and overall survival | up to 2 years after transplantation |
| Seoul |
| 138-736 |
| South Korea |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D000013 | Congenital Abnormalities |
| D015470 | Leukemia, Myeloid, Acute |
| D015479 | Leukemia, Myelomonocytic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| D007947 | Leukemia, Megakaryoblastic, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D008727 | Methotrexate |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus 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 |
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