Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060346
Status:
TERMINATED
Last Update Posted:
2023-06-29
First Post:
2003-05-06
Brief Title:
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstroms Macroglobulinemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstroms Macroglobulinemia
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die Combining rituximab 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 patients with newly diagnosed Waldenstroms macroglobulinemia
PURPOSE This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES
Determine the response rate of patients with newly diagnosed Waldenstroms macroglobulinemia treated with rituximab cyclophosphamide doxorubicin vincristine and prednisone
Determine the associated toxic effects of this regimen specifically the frequency of febrile neutropenia in these patients
Determine the progression-free survival of patients treated with this regimen
Correlate baseline cytogenetic features and gene expression profiles with response in patients treated with this regimen
OUTLINE This is a pilot multicenter study
Patients receive rituximab intravenously IV over approximately 4 hours cyclophosphamide IV over 5-30 minutes doxorubicin IV over 5-15 minutes and vincristine IV over 1 minute on day 1 Patients also receive oral prednisone on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
ACTUAL ACCRUAL A total of 16 patients were accrued for this study
Determine the response rate of patients with newly diagnosed Waldenstroms macroglobulinemia treated with rituximab cyclophosphamide doxorubicin vincristine and prednisone
Determine the associated toxic effects of this regimen specifically the frequency of febrile neutropenia in these patients
Determine the progression-free survival of patients treated with this regimen
Correlate baseline cytogenetic features and gene expression profiles with response in patients treated with this regimen
OUTLINE This is a pilot multicenter study
Patients receive rituximab intravenously IV over approximately 4 hours cyclophosphamide IV over 5-30 minutes doxorubicin IV over 5-15 minutes and vincristine IV over 1 minute on day 1 Patients also receive oral prednisone on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
ACTUAL ACCRUAL A total of 16 patients were 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 |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E1A02 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |