Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049036
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2002-11-12
Brief Title:
Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I Stage II Stage III or Stage IV Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of EPOCH Given Either Concurrently or Sequentially With Rituximab in Patients With Intermediate- or High-Grade HIV-Associated B-cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This randomized phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with HIV-associated stage I stage II stage III or stage IV non-Hodgkins lymphoma Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the complete response rate after treatment with EPOCH given either concurrently or sequentially with rituximab
SECONDARY OBJECTIVES
I To evaluate the toxicity of EPOCH given either concurrently or sequentially with rituximab
II To evaluate the effect of EPOCH given either concurrently or sequentially with rituximab on immune function CD4 CD8 lymphocyte count after two cycles of EPOCH and 1 month 3 months 6 months and 12 months after the completion of EPOCH
III To evaluate the effect of EPOCH given either concurrently or sequentially with rituximab on HIV and EBV viral load after two cycles of EPOCH and 1 month 3 months 6 months and 12 months after the completion of EPOCH
IV To evaluate the relationship between EBV viral load and EBV CD8 cytotoxic T cells in the peripheral blood and the presence of EBV in lymphoma tumor cells
V To determine whether rituximab or the concurrent use of antiretroviral therapy significantly alters the steady state concentration of etoposide doxorubicin or vincristine during the first cycle of therapy
VI To determine whether steady state concentration of etoposide or doxorubicin correlate with nadir neutrophil and platelet count during the first cycle of therapy
VII To determine time to progression and overall survival in patients treated with EPOCH given either concurrently or sequentially with rituximab
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to CD4 count less than 100mm3 vs at least 100mm3 age-adjusted International Prognostic Index adverse risk factors 0 or 1 vs 2 or 3 and concurrent antiretroviral therapy yes vs no Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive rituximab intravenously IV over 2-4 hours prior to each course of chemotherapy Treatment repeats every 3 weeks for 4-6 courses Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks
ARM II Patients do not receive rituximab concurrently with chemotherapy Beginning 4 weeks after completion of chemotherapy patients receive rituximab IV over 2-4 hours weekly for 6 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To determine the complete response rate after treatment with EPOCH given either concurrently or sequentially with rituximab
SECONDARY OBJECTIVES
I To evaluate the toxicity of EPOCH given either concurrently or sequentially with rituximab
II To evaluate the effect of EPOCH given either concurrently or sequentially with rituximab on immune function CD4 CD8 lymphocyte count after two cycles of EPOCH and 1 month 3 months 6 months and 12 months after the completion of EPOCH
III To evaluate the effect of EPOCH given either concurrently or sequentially with rituximab on HIV and EBV viral load after two cycles of EPOCH and 1 month 3 months 6 months and 12 months after the completion of EPOCH
IV To evaluate the relationship between EBV viral load and EBV CD8 cytotoxic T cells in the peripheral blood and the presence of EBV in lymphoma tumor cells
V To determine whether rituximab or the concurrent use of antiretroviral therapy significantly alters the steady state concentration of etoposide doxorubicin or vincristine during the first cycle of therapy
VI To determine whether steady state concentration of etoposide or doxorubicin correlate with nadir neutrophil and platelet count during the first cycle of therapy
VII To determine time to progression and overall survival in patients treated with EPOCH given either concurrently or sequentially with rituximab
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to CD4 count less than 100mm3 vs at least 100mm3 age-adjusted International Prognostic Index adverse risk factors 0 or 1 vs 2 or 3 and concurrent antiretroviral therapy yes vs no Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive rituximab intravenously IV over 2-4 hours prior to each course of chemotherapy Treatment repeats every 3 weeks for 4-6 courses Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks
ARM II Patients do not receive rituximab concurrently with chemotherapy Beginning 4 weeks after completion of chemotherapy patients receive rituximab IV over 2-4 hours weekly for 6 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| NCI-2012-02926 | REGISTRY | None | None |
| ECOG-AMC34 | None | None | None |
| CDR0000257660 | None | None | None |
| AMC-034 | OTHER | None | None |
| AMC-034 | OTHER | None | None |
| U01CA070019 | NIH | CTEP | httpsreporternihgovquickSearchU01CA070019 |