Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031902
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2002-03-08
Brief Title:
Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkins Lymphoma
Sponsor:
Lymphoma Trials Office
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Rituxumab Combined With Chemotherapy PVB For Poor Prognosis HIV-Related Non-Hodgkins 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-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate of patients with poor-prognosis HIV-related non-Hodgkins 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-Hodgkins 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20145 | None | None | None |
| BNLI-POORRISKHIV | None | None | None |