Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265837
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2005-12-14
Brief Title:
Laboratory-Treated Donor Bone Marrow in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase III Trial of T Lymphocyte Depletion by Elutriation and CD34 Add-Back for Allogeneic Bone Marrow Transplantation
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patients immune system from rejecting the donors stem cells When certain stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Removing the T cells from the donor cells before transplant may stop this from happening
PURPOSE This randomized phase III trial is studying donor bone marrow that is treated in the laboratory using two different devices to compare how well they work in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer
PURPOSE This randomized phase III trial is studying donor bone marrow that is treated in the laboratory using two different devices to compare how well they work in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer
Detailed Description:
OBJECTIVES
Compare the effectiveness in terms of incidence of graft failure and incidence of greater than grade 1 acute graft-vs-host disease of ex vivo manipulation of bone marrow cells comprising counterflow centrifugal elutriation for T-lymphocyte depletion followed by CD34-positive stem cell selection using CliniMACS vs Isolex 300i in patients with a hematologic malignancy undergoing allogeneic bone marrow transplantation from an HLA-identical sibling donor
OUTLINE This is a randomized study Patients are stratified by age 40 vs 40-65 and disease status low-risk ie chronic phase chronic myelogenous leukemia acute myeloid leukemia in first complete remission CR acute lymphocytic leukemia in first CR Hodgkins or non-Hodgkins lymphoma in sensitive relapse or multiple myeloma in CR or partial remission vs high-risk ie all others Patients are randomized to 1 of 2 treatment arms
Arm I Allogeneic bone marrow cells are subjected to counterflow centrifugal elutriation CCE for T-lymphocyte depletion The elutriation fractions are then processed over 2-25 hours using CliniMACS to select for CD34-positive stem cells
Arm II Allogeneic bone marrow cells are subjected to CCE for T-lymphocyte depletion The elutriation fractions are then processed over 4-45 hours using Isolex 300i to select for CD34-positive stem cells
Patients in both arms then undergo ex vivo manipulated T-lymphocyte-depleted CD34-positive stem cell-selected allogeneic bone marrow transplantation on day 0
After the transplantation patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 206 patients will be accrued for this study
Compare the effectiveness in terms of incidence of graft failure and incidence of greater than grade 1 acute graft-vs-host disease of ex vivo manipulation of bone marrow cells comprising counterflow centrifugal elutriation for T-lymphocyte depletion followed by CD34-positive stem cell selection using CliniMACS vs Isolex 300i in patients with a hematologic malignancy undergoing allogeneic bone marrow transplantation from an HLA-identical sibling donor
OUTLINE This is a randomized study Patients are stratified by age 40 vs 40-65 and disease status low-risk ie chronic phase chronic myelogenous leukemia acute myeloid leukemia in first complete remission CR acute lymphocytic leukemia in first CR Hodgkins or non-Hodgkins lymphoma in sensitive relapse or multiple myeloma in CR or partial remission vs high-risk ie all others Patients are randomized to 1 of 2 treatment arms
Arm I Allogeneic bone marrow cells are subjected to counterflow centrifugal elutriation CCE for T-lymphocyte depletion The elutriation fractions are then processed over 2-25 hours using CliniMACS to select for CD34-positive stem cells
Arm II Allogeneic bone marrow cells are subjected to CCE for T-lymphocyte depletion The elutriation fractions are then processed over 4-45 hours using Isolex 300i to select for CD34-positive stem cells
Patients in both arms then undergo ex vivo manipulated T-lymphocyte-depleted CD34-positive stem cell-selected allogeneic bone marrow transplantation on day 0
After the transplantation patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 206 patients will be accrued for this study
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 |
|---|---|---|---|
| P01CA015396 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0165 | None | None | None |
| JHOC-WIRB-1908 | None | None | None |
| JHOC-WIRB-20020342 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |