Ignite Creation Date:
2024-05-06 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03626285
Status:
AVAILABLE
Last Update Posted:
2023-08-01
First Post:
2018-06-27
Brief Title:
Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Institutional Protocol of Bone Marrow Transplantation Using CD34-Selected Peripheral Blood Stem Cells From Related Haploidentical or Unrelated Donors for Treatment of Malignant and Nonmalignant Disorders
Status:
AVAILABLE
Status Verified Date:
2024-08
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:
This expanded access protocol studies bone marrow transplantation using CD34-selected stem cells from related or unrelated donors in treating participants with cancer or other disorders Stem cells collected from the donor will be processed using a new device called CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a special protein called antibody that tags only the donor stem cells sorting out other cells of the blood and immune system This is done to remove at least partially some of the T cells T cells are the cells in the blood that work as scavengers of the immune system deciding what belongs and what does not These cells can sometimes cause rejection of the donor graft or a condition called graft-versus host disease GVHD where the donor cells can attack the body of the recipient A bone marrow transplantation using CD34-selected stem cells may reduce the risk of these unwanted side effects of transplant as much as possible
Detailed Description:
PRIMARY OBJECTIVES
I To provide a source of CD34-selected stem cells for patients with malignant and nonmalignant disorders undergoing bone marrow transplantation from haploidentical human leukocyte antigen HLA-mismatched related donors or HLA-compatible unrelated donors
SECONDARY OBJECTIVES
I Monitoring the safety of the CD34-selected stem cells for the recipient as measured by adverse events related to stem cell infusion incidence of engraftment of neutrophils and platelets incidence of acute and chronic GVHD and one year overall survival disease-free survival and primary disease recurrence
OUTLINE
Donor stem cells undergo CD34 selection ex vivo using the CliniMACS CD34 Reagent System using standard operating procedures SOPs from the manufacturer Recipients undergo standard of care preparative regimen bone marrow transplantation with CD34-selected peripheral blood stem cells via infusion over 1 to 2 hours on day 0 and then receive standard of care GVHD prophylaxis
After completion of study treatment recipients are followed up at least once weekly while inpatient until transplant day 100 every 1-3 months for the first year and yearly thereafter
I To provide a source of CD34-selected stem cells for patients with malignant and nonmalignant disorders undergoing bone marrow transplantation from haploidentical human leukocyte antigen HLA-mismatched related donors or HLA-compatible unrelated donors
SECONDARY OBJECTIVES
I Monitoring the safety of the CD34-selected stem cells for the recipient as measured by adverse events related to stem cell infusion incidence of engraftment of neutrophils and platelets incidence of acute and chronic GVHD and one year overall survival disease-free survival and primary disease recurrence
OUTLINE
Donor stem cells undergo CD34 selection ex vivo using the CliniMACS CD34 Reagent System using standard operating procedures SOPs from the manufacturer Recipients undergo standard of care preparative regimen bone marrow transplantation with CD34-selected peripheral blood stem cells via infusion over 1 to 2 hours on day 0 and then receive standard of care GVHD prophylaxis
After completion of study treatment recipients are followed up at least once weekly while inpatient until transplant day 100 every 1-3 months for the first year and yearly thereafter
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 |
|---|---|---|---|
| NCI-2018-00556 | REGISTRY | None | None |
| IRB00010804 | OTHER | OHSU Knight Cancer Institute | None |