Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00031902
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2002-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Sponsor:
Lymphoma Trials Office
Organization:
Study Overview
Official Title:
Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma
Status:
UNKNOWN
Status Verified Date:
2003-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 such as rituximab can locate tumor cells and either kill them or deliver tumor-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 rituximab with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
Detailed Description:
OBJECTIVES:
* Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.
* Determine the toxicity of this regimen in these patients.
* Determine the time to progression and survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.
Patients are followed every 1-2 months.
PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.
* Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.
* Determine the toxicity of this regimen in these patients.
* Determine the time to progression and survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.
Patients are followed every 1-2 months.
PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: