Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001432
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
The Collection of Peripheral Blood Lymphocytes and Marrow Progenitor Cells From Normal Volunteers and Volunteers With Lymphoid or Hematologic Malignancies
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Collection of Peripheral Blood Lymphocytes and Marrow Progenitor Cells From Normal Volunteers and Volunteers With Lymphoid or Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2003-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Allogeneic bone marrow transplantation BMT is a curative treatment for patients with chronic myelogenous leukemia CML and other lymphoidhematologic 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 66-2H2 or U-13C9-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 lymphoidhematologic malignancies An infusion of 66-2H2 or U-13C9-glucose prior to bone marrow andor leukocyte harvest in some volunteers will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations 66-2H2 or U-13C9-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 lymphoidhematologic 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 66-2H2 or U-13C9-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 lymphoidhematologic malignancies An infusion of 66-2H2 or U-13C9-glucose prior to bone marrow andor leukocyte harvest in some volunteers will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations 66-2H2 or U-13C9-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-C-0086 | None | None | None |