Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510887
Status:
TERMINATED
Last Update Posted:
2014-05-12
First Post:
2007-08-01
Brief Title:
Bortezomib Velcade With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase II Study of Bortezomib in Combination With Rituximab Fludarabine Mitoxantrone and Dexamethasone VR-FND for Relapsed or Refractory Follicular Lymphoma
Status:
TERMINATED
Status Verified Date:
2014-04
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 evaluate the effectiveness and safety of combining bortezomib Velcade with rituximab fludarabine mitoxantrone and dexamethasone in treating patients with follicular cell lymphoma
Detailed Description:
This is a phase II study using the combination of bortezomib rituximab fludarabine mitoxantrone and dexamethasone The combination will given over a 28 day cycle In addition each patient will receive Pneumocystis carinii Pneumonia PCP prophylaxis with Trimethoprimsulfamethoxazole TMPSulfa or equivalent agent On day 4 the physician has the option of starting granulocyte colony-stimulating factor GCSF granulocyte macrophage colony-stimulating factor GMCSF or pegylated GCSF
All patients who receive at least one dose of the drug will be evaluated for toxicity Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response The chemotherapy dosing will continue until there is evidence of disease progression a second recurrence of unacceptable toxicity or a maximum of 8 courses of therapy
All patients who receive at least one dose of the drug will be evaluated for toxicity Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response The chemotherapy dosing will continue until there is evidence of disease progression a second recurrence of unacceptable toxicity or a maximum of 8 courses of therapy
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 |
|---|---|---|---|
| 8785 | OTHER | DUMC old IRB number | None |