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| ID | Type | Description | Link |
|---|---|---|---|
| FHCRC-2041.00 | |||
| GEMZYME-FHCRC-2041.00 | |||
| CDR0000488969 | Registry Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal or cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and methotrexate works in treating patients with myeloid cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | |||
| busulfan | Drug | |||
| fludarabine phosphate | Drug | |||
| methotrexate | Drug | |||
| tacrolimus | Drug | |||
| allogeneic hematopoietic stem cell transplantation | Procedure | |||
| peripheral blood stem cell transplantation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of acute graft-versus-host disease (GVHD) | ||
| Incidence of donor engraftment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of IV busulfan including interdose variability and evaluation of a limited sampling strategy | ||
| Pharmacokinetics of antithymocyte globulin | ||
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following myeloid malignancies:
Chronic myelogenous leukemia meeting 1 of the following criteria:
Acute myeloid leukemia meeting 1 of the following criteria:
Myelodysplastic syndromes, including all risk groups
Other myeloproliferative disorders
HLA-A, -B, -C, -DRB1, and -DQB1 matched related or unrelated donor available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Paul V. O'Donnell, MD, PhD | Fred Hutchinson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
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| Pharmacokinetics of fludarabine phosphate and its effect on lymphocytes |
| Incidence of specific toxic effects ≥ grade 3 |
| Incidence and severity of chronic GVHD |
| Incidence of nonrelapsing mortality at 100 days and at 1 year after transplantation |
| Incidence of relapse |
| Relapse-free survival |
| Incidence of Epstein-Barr virus activation and post-transplantation lymphoproliferative disease |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D006086 | Graft vs Host Disease |
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D001752 | Blast Crisis |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D015470 | Leukemia, Myeloid, Acute |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D055728 | Primary Myelofibrosis |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D002066 | Busulfan |
| C042382 | fludarabine phosphate |
| D008727 | Methotrexate |
| D016559 | Tacrolimus |
| 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 |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| 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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