Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004143
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
1999-12-10
Brief Title:
Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies Bone Marrow Failure Syndromes
Sponsor:
David Rizzieri MD
Organization:
Duke University
Study Overview
Official Title:
Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro Campath for Hemoglobinopathies and Bone Marrow Failure Syndromes
Status:
COMPLETED
Status Verified Date:
2014-11
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:
RATIONALE Although used primarily to treat malignant disorders of the blood allogeneic stem cell transplantation can also cure a variety of non-cancerous inherited or acquired disorders of the blood Unfortunately the conventional approach to allogeneic stem cell transplantation is a risky procedure For some non-cancerous conditions the risks of this procedure outweigh the potential benefits This protocol is designed to test a new approach to allogeneic stem cell transplantation It is hoped that this approach will be better suited for patients with non-cancerous blood and bone marrow disorders
Detailed Description:
OBJECTIVES
Primary Objectives
1 Evaluate the feasibility in terms of mortality occurrence of acute graft versus host disease and grades 3-44 toxicity of in vivo and in vitro Campath coupled with concomitantly administered nonmyeloablative fludarabine cyclophosphamide and total body irradiation TBI followed by Human Leukocyte Antigen HLA 5-66 matched family member allo peripheral blood stem cell transplant PBSCT
2 Evaluate the engraftment rate of HLA 5-66 matched family member patients who receive in vivo Campath followed by concomitantly administered fludarabine cyclophosphamide and total body irradiation TBI as a conditioning regimen with Campath-treated peripheral blood stem cells in vitro and in vivo exposure
Secondary Objectives
1 Evaluate the response rate and survival of patients who receive a non-myeloablative conditioning regimen of in vivo Campath followed by concomitantly administered fludarabine cyclophosphamide and total body irradiation TBI with Campath-treated peripheral blood stem cells
2 Evaluate the recovery of immune function post engraftment with this regimen
Primary Objectives
1 Evaluate the feasibility in terms of mortality occurrence of acute graft versus host disease and grades 3-44 toxicity of in vivo and in vitro Campath coupled with concomitantly administered nonmyeloablative fludarabine cyclophosphamide and total body irradiation TBI followed by Human Leukocyte Antigen HLA 5-66 matched family member allo peripheral blood stem cell transplant PBSCT
2 Evaluate the engraftment rate of HLA 5-66 matched family member patients who receive in vivo Campath followed by concomitantly administered fludarabine cyclophosphamide and total body irradiation TBI as a conditioning regimen with Campath-treated peripheral blood stem cells in vitro and in vivo exposure
Secondary Objectives
1 Evaluate the response rate and survival of patients who receive a non-myeloablative conditioning regimen of in vivo Campath followed by concomitantly administered fludarabine cyclophosphamide and total body irradiation TBI with Campath-treated peripheral blood stem cells
2 Evaluate the recovery of immune function post engraftment with this regimen
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 |
|---|---|---|---|
| CDR0000067374 | Other GrantFunding Number | National Cancer Institute | None |
| DUMC-1340-99-7 | OTHER | None | None |
| NCI-G99-1617 | OTHER_GRANT | None | None |