Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225212
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2005-09-21
Brief Title:
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkins Lymphoma
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2014-09
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:
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas but is limited by relapse occurs in 40 to 50 of subjects
This study assesses autologous stem cell transplant ASCT supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas as an alternative to the limitations of conventional therapy
Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50 with very little toxicity Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen rituximab has impressive independent anti-tumor activity and the antibody has little toxicity outside of the acute administration
This study assesses autologous stem cell transplant ASCT supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas as an alternative to the limitations of conventional therapy
Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50 with very little toxicity Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen rituximab has impressive independent anti-tumor activity and the antibody has little toxicity outside of the acute administration
Detailed Description:
The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mgm2 starting 6 weeks after ASCT transplant
After an observation period to assess acute and late toxicity for the first 4 subjects subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT
After an observation period to assess acute and late toxicity for the first 4 subjects subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT
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 |
|---|---|---|---|
| 73750 | OTHER | Stanford IRB old system | None |