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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053157 |
RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem cell donor and the patient may reduce the chance of developing graft-versus-host disease following stem cell transplantation.
PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia.
Condition | Intervention |
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Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: sargramostim |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | Use Of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) To Mobilize Donor Peripheral Blood Stem Cells Along With GM-CSF Administration Post Allogeneic Transplant - A Pilot Study |
Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a pilot study.
PROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.
Ages Eligible for Study: | 5 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of a malignant hematologic disease, including:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Philip L. McCarthy, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000269288, RPCI-RPC-0201 |
Study First Received: | January 27, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00053157 History of Changes |
Health Authority: | United States: Federal Government |
graft versus host disease accelerated phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia chronic idiopathic myelofibrosis childhood acute myeloid leukemia/other myeloid malignancies childhood acute promyelocytic leukemia (M3) recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent/refractory childhood Hodgkin lymphoma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
meningeal chronic myelogenous leukemia noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma |
Aplastic Anemia Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Graft Versus Host Disease Preleukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Promyelocytic, Acute Neoplasm Metastasis Hodgkin Disease Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immunoproliferative Disorders Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myeloproliferative Disorders Leukemia, Myeloid B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions Hodgkin Lymphoma, Childhood |
Disease Immunoproliferative Disorders Neoplasms by Histologic Type Precancerous Conditions Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Lymphatic Diseases Leukemia Preleukemia |
Neoplasms Pathologic Processes Syndrome Lymphoma, Large-Cell, Immunoblastic Graft vs Host Disease Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Myelodysplastic-Myeloproliferative Diseases Lymphoma |