Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101010
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2005-01-07
Brief Title:
Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2020-09
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 such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Drugs used in chemotherapy work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving rituximab together with combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab cyclophosphamide pegylated doxorubicin hydrochloride liposome HCl vincristine and prednisone
Determine the cardiotoxicity and myelosuppression of this regimen in these patients
Secondary
Determine disease-free survival and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive rituximab intravenous IV cyclophosphamide IV over 1-1½ hours pegylated doxorubicin HCl liposome IV over 1 hour and vincristine IV on day 1 and oral prednisone on days 1-5 Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 24 hours after the completion of chemotherapy Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity disease progression active hepatitis B virus infection or hepatitis Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study
Patients are followed at 1 month every 3 months for 1 year every 4 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 80 patients will be accrued for this study within 27 months
Primary
Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab cyclophosphamide pegylated doxorubicin hydrochloride liposome HCl vincristine and prednisone
Determine the cardiotoxicity and myelosuppression of this regimen in these patients
Secondary
Determine disease-free survival and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive rituximab intravenous IV cyclophosphamide IV over 1-1½ hours pegylated doxorubicin HCl liposome IV over 1 hour and vincristine IV on day 1 and oral prednisone on days 1-5 Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 24 hours after the completion of chemotherapy Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity disease progression active hepatitis B virus infection or hepatitis Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study
Patients are followed at 1 month every 3 months for 1 year every 4 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 80 patients will be accrued for this study within 27 months
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 |
|---|---|---|---|
| 2U10CA045809 | NIH | NCI CTRP | httpsreporternihgovquickSearch2U10CA045809 |
| MDA-CCOP-2004-0305 | None | None | None |
| NCI-6485 | None | None | None |
| 2004-0305 | OTHER | None | None |
| NCI-2009-00064 | REGISTRY | None | None |