Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481832
Status:
TERMINATED
Last Update Posted:
2018-02-14
First Post:
2007-05-31
Brief Title:
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkins Lymphoma
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual Factor
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 trial is to develop an alternative treatment for patients with poor risk non-Hodgkins lymphoma This trial uses a combination of high dose chemotherapy with stem cell transplant using the patients own cells This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system
Detailed Description:
Currently patients with recurrent or primary refractory non-Hodgkins lymphoma are treated with second-line chemotherapy usually 2-3 courses for the purpose of cytoreduction and to establish sensitivity to chemotherapy Thereafter peripheral blood progenitor cells are mobilized with cyclophosphamide and granulocyte colony stimulating factor apheresed and cryopreserved The standard high dose regimen consists of augmented carmustine etoposide and cyclophosphamide Unfortunately there are subgroups of patients with poor outcomes using autologous transplantation including those with transformed lymphoma as well as patients who do not attain a minimal disease state due to chemoresistant disease
These groups of patients have limited disease control and survival with standard chemotherapy regimens and although they often have excellent cytoreduction with the high-dose chemotherapy regimen relapse remains the primary cause of treatment failure The current trial utilizes a similar approach that has been taken with patients with multiple myeloma who appear to benefit from an allogeneic graft-versus-tumor effect using a combined autologous and non-myeloablative allogeneic transplant regimen to reduce transplant-related complications Eligible patients will be treated with high-dose chemotherapy using BCNU etoposide and cyclophosphamide with autologous hematopoietic cell support as a method of cytoreduction Approximately 60-120 days after the autologous transplant patients will receive an allogeneic transplant using a preparative regimen of total lymphoid irradiation and anti-thymocyte globulin in an attempt to develop a graft-versus-lymphoma effect
These groups of patients have limited disease control and survival with standard chemotherapy regimens and although they often have excellent cytoreduction with the high-dose chemotherapy regimen relapse remains the primary cause of treatment failure The current trial utilizes a similar approach that has been taken with patients with multiple myeloma who appear to benefit from an allogeneic graft-versus-tumor effect using a combined autologous and non-myeloablative allogeneic transplant regimen to reduce transplant-related complications Eligible patients will be treated with high-dose chemotherapy using BCNU etoposide and cyclophosphamide with autologous hematopoietic cell support as a method of cytoreduction Approximately 60-120 days after the autologous transplant patients will receive an allogeneic transplant using a preparative regimen of total lymphoid irradiation and anti-thymocyte globulin in an attempt to develop a graft-versus-lymphoma effect
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 |
|---|---|---|---|
| BMT185 | OTHER | OnCore | None |
| 97623 | OTHER | None | None |