Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434629
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2007-02-12
Brief Title:
Safety and Efficacy of Bexxar Therapy in the Treatment of RelapsedResidual B-Cell Lymphoma After Autologous Transplant
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Phase I Study of Bexxar Tositumomab and 131I-Tositumomab Radioimmunotherapy in Patients With Relapsed or Residual CD20 Antigen-Expressing B-Cell Lymphomas Following Autologous Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2016-08
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:
Patients with B-cell lymphoma who relapse after autologous transplant tend to have a poor prognosis Currently there is no standard treatment for such patients Bexxar is a radioactive antibody therapy that has shown a 60-80 response rate in non-transplanted patients with relapsed B-cell lymphoma This study will test the safety and efficacy of Bexxar in the treatment of patients whose B-cell lymphoma has relapsed after an autologous transplant
Detailed Description:
High-dose chemotherapy followed by autologous stem cell transplantation ASCT has become the standard of care for relapsedrefractory chemotherapy-sensitive non-Hodgkins lymphomas NHL However one-half to two-thirds of such patients will relapse after ASCT with subsequent poor prognosis and new therapies are urgently needed for this patient population Radioimmunotherapy RIT as a single agent therapy in patients with CD20 antigen-expressing relapsed or refractory low-grade follicular or transformed NHL has demonstrated overall response rates of 60-80 and has been approved by the FDA for use in this setting While RIT is currently under investigation as a component of conditioning regimens for ASCT the safety and efficacy of RIT after ASCT has not yet been well described We will conduct a single-center Phase I dose-escalation trial of Bexxar Tositumomab and 131I Tositumomab for treatment of relapsed or residual CD20 antigen-expressing B-cell lymphomas following ASCT Our primary aim will be to determine the safety dose-limiting toxicity and maximum tolerated dose of Bexxar in this post-ASCT patient population Our secondary aim will be to describe the overall response rate progression-free survival time to treatment failure and overall survival Should Bexxar prove to be safe in this population subsequent trials will be designed to investigate further the efficacy of RIT in the post-transplant setting
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 |
|---|---|---|---|
| GSK 106665 | None | None | None |
| UPenn IRB805353 | None | None | None |