Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482053
Status:
TERMINATED
Last Update Posted:
2018-05-14
First Post:
2007-05-31
Brief Title:
Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma DLBCL who are not likely to be cured by the conventional transplantation regimen
Detailed Description:
This study tests a tandem transplant approach that starts with transplantation of the participants own hematopoietic blood cells eg autologous hematopoietic cell transplant auto-HCT as preparation for an subsequent matched-donor allogeneic HCT allo-HCT
Participants will be have progenitor cells stem cells mobilized into the peripheral blood with rituximab chemotherapy cyclophosphamide or etoposide and filgrastim G-CSF undergo apheresis to collect autologous peripheral blood stem cells PBSC aka hematopoietic cells and be re-infused with 3 x 10e6 CD34 cellskg auto-HCT Subsequently participants will receive therapeutic non-myeloablative chemotherapy carmustine cyclophosphamide etoposide then transplant conditioning total lymphoid irradiation TLI anti-thymocyte globulin ATG followed by 2 x 10e6 CD34 cellskg allogeneic PBSC obtained from a human leukocyte antigen HLA-matched or HLA single allele antigen-mismatched donor allo-HCT Donors will be mobilized with 16 µgkg filgrastim Participant allo-HCT transplant is to occur within 150 days of auto-HCT Post-allo-HCT infusion treatment includes cyclosporine and mycophenolate mofetil MMF
Subjects participation ends if a suitable matched donor is not identified within the 150 days
Pre-medication treatments administered during this study may include acetaminophen diphenhydramine hydrocortisone and methylprednisolone
Participants will be have progenitor cells stem cells mobilized into the peripheral blood with rituximab chemotherapy cyclophosphamide or etoposide and filgrastim G-CSF undergo apheresis to collect autologous peripheral blood stem cells PBSC aka hematopoietic cells and be re-infused with 3 x 10e6 CD34 cellskg auto-HCT Subsequently participants will receive therapeutic non-myeloablative chemotherapy carmustine cyclophosphamide etoposide then transplant conditioning total lymphoid irradiation TLI anti-thymocyte globulin ATG followed by 2 x 10e6 CD34 cellskg allogeneic PBSC obtained from a human leukocyte antigen HLA-matched or HLA single allele antigen-mismatched donor allo-HCT Donors will be mobilized with 16 µgkg filgrastim Participant allo-HCT transplant is to occur within 150 days of auto-HCT Post-allo-HCT infusion treatment includes cyclosporine and mycophenolate mofetil MMF
Subjects participation ends if a suitable matched donor is not identified within the 150 days
Pre-medication treatments administered during this study may include acetaminophen diphenhydramine hydrocortisone and methylprednisolone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMT186 | OTHER | OnCore number | None |
| 97355 | OTHER | None | None |