Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT00001432
Brief Summary:
Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Autologous BMT, coupled with high dose chemotherapy, is a treatment open to more patients and is a promising strategy for the treatment of advanced solid malignancies. However, the development of potentially curative marrow transplant alternatives requires an ability to provide a nonmalignant hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage subtypes following reinfusion are critical to understanding the biology and immunological consequences of stem cell transplantation. An increased understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the identification of donor cell populations that mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or without prior \[6,6-(2)H(2)\] or \[U-(13)C(9)\]-glucose, infusion to provide cell populations which will then be utilized for specific pre-clinical studies aimed at developing new therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies. An infusion of \[6,6-(2)H(2)\] or \[U-(13)C(9)\]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. \[6,6-(2)H(2)\] or \[U-(13)C(9)\]-glucose, are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and is chemically identical to glucose, with no adverse side effects other than those known for glucose.
Detailed Description:
Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Autologous BMT, coupled with high dose chemotherapy, is a treatment open to more patients and is a promising strategy for the treatment of advanced solid malignancies. However, the development of potentially curative marrow transplant alternatives requires an ability to provide a nonmalignant hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage subtypes following reinfusion are critical to understanding the biology and immunological consequences of stem cell transplantation. An increased understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the identification of donor cell populations that mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or without prior \[6,6-(2)H2\] or \[U-(13)C9\]-glucose, infusion to provide cell populations which will then be utilized for specific pre-clinical studies aimed at developing new therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies. An infusion of \[6,6-(2)H2\] or \[U-(13)C9\]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. \[6,6-(2)H2\] or \[U-(13)C9\]-glucose, are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and is chemically identical to glucose, with no adverse side effects other than those known for glucose.
Study:
NCT00001432
Study Brief:
Protocol Section:
NCT00001432