Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003963
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
1999-11-01
Brief Title:
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With B-cell Non-Hodgkins Lymphoma That Has Relapsed Following Peripheral Stem Cell Transplantation
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination
Status:
COMPLETED
Status Verified Date:
2012-07
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 Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkins lymphoma that has relapsed following autologous peripheral stem cell transplantation
PURPOSE Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkins lymphoma that has relapsed following autologous peripheral stem cell transplantation
Detailed Description:
OBJECTIVES
Determine the tolerability and toxicity of rituximab combined with vinorelbine in patients with relapsed non-Hodgkins lymphoma following autologous peripheral blood stem cell transplantation
Assess the response rate and duration of response to this regimen in these patients
OUTLINE Patients receive rituximab IV weekly on weeks 1-4 6 8 10 and 12 and vinorelbine IV on weeks 2-4 6-8 and 10-12 Patients who achieve partial response may continue on vinorelbine from week 14 until disease progression
Patients are followed until disease progression
PROJECTED ACCRUAL A total of 18-25 patients will be accrued for this study
Determine the tolerability and toxicity of rituximab combined with vinorelbine in patients with relapsed non-Hodgkins lymphoma following autologous peripheral blood stem cell transplantation
Assess the response rate and duration of response to this regimen in these patients
OUTLINE Patients receive rituximab IV weekly on weeks 1-4 6 8 10 and 12 and vinorelbine IV on weeks 2-4 6-8 and 10-12 Patients who achieve partial response may continue on vinorelbine from week 14 until disease progression
Patients are followed until disease progression
PROJECTED ACCRUAL A total of 18-25 patients will be accrued for this study
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 |
|---|---|---|---|
| UCLA-9903029 | None | None | None |
| NCI-G99-1545 | None | None | None |