Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006436
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2000-11-03
Brief Title:
EPOCH and Rituximab to Treat Non-Hodgkins Lymphoma in Patients With HIV Infection
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Short-Course EPOCH - Rituximab in Untreated CD-20 HIV-Associated Lymphomas
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Background
Human immunodeficiency virus HIV-infected patients have a weakened immune system and chemotherapy which is used to treat lymphoma probably causes further damage to the immune system
Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkins lymphoma
Objectives
To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R etoposide doxorubicin vincristine cyclophosphamide and rituximab will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers
To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission
Eligibility
-Patients with non-Hodgkins lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy
Design
Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles
The lymphoma is evaluated using computed tomography CT and positron emission tomography PET scans at the end of treatment cycles 2 and 3 A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study
Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R treatment ends
Patients are monitored for treatment response with blood tests and imaging scans at baseline when treatment ends 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy
Human immunodeficiency virus HIV-infected patients have a weakened immune system and chemotherapy which is used to treat lymphoma probably causes further damage to the immune system
Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkins lymphoma
Objectives
To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R etoposide doxorubicin vincristine cyclophosphamide and rituximab will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers
To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission
Eligibility
-Patients with non-Hodgkins lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy
Design
Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles
The lymphoma is evaluated using computed tomography CT and positron emission tomography PET scans at the end of treatment cycles 2 and 3 A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study
Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R treatment ends
Patients are monitored for treatment response with blood tests and imaging scans at baseline when treatment ends 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy
Detailed Description:
Background
This is a study to investigate in a preliminary fashion the feasibility of short course chemotherapy to participants with HIV-associated non-Hodgkins lymphoma HIV-NHL
This study will investigate if the paradigm for treatment can be successfully changed from a standard of 6 cycles to one cycle beyond complete remission with 6 total allowable cycles
Objective
To assess with 90 percent probability that at least 50 percent of participants treated with short-course EPOCH-R etoposide doxorubicin vincristine cyclophosphamide and rituximab will be progression free at one year
Eligibility
Aggressive B-lymphocyte antigen CD20 CD20 positive Diffuse large B cell lymphoma DLBCL
HIV serology
All stages I-IV of disease
Eastern Cooperative Oncology Group ECOG Performance status 0-4
Non-Hodgkins Lymphoma NHL previously untreated with cytotoxic chemotherapy
Age greater than or equal to 18 years
May not be pregnant or nursing
May not have received previous rituximab
Design
Participants will be treated every three weeks with a combination of EPOCH and rituximab for one cycle beyond complete remission CRcomplete response unconfirmed CRu by computed tomography CT scan of all detectable tumors for a minimum of three and maximum of six cycles Following cycle 2 CT positron emission tomography scans PET and bone marrow biopsies if initially positive will be performed
At the conclusion of the study we will estimate whether the number of cycles can be reduced using the paradigm If the cumulative number of participants to relapse exceeds 25 percent by 6 months the study will be closed
Following the completion of chemotherapy restaging will be performed 2 months following the end of treatment then every 3 months for one year every 6 months for one year then every 12 months until relapse death or loss to follow up
Antiretroviral therapy ART will be given concurrently with treatment regimen
To study the effects of treatment approach on parameters of HIV disease measurements of cluster of differentiation 4 CD4 cells and viral loads will be made at baseline and at the completion of therapy and then 2 months following the end of treatment and then every 3-6 months for a total of 24 months following chemotherapy
This is a study to investigate in a preliminary fashion the feasibility of short course chemotherapy to participants with HIV-associated non-Hodgkins lymphoma HIV-NHL
This study will investigate if the paradigm for treatment can be successfully changed from a standard of 6 cycles to one cycle beyond complete remission with 6 total allowable cycles
Objective
To assess with 90 percent probability that at least 50 percent of participants treated with short-course EPOCH-R etoposide doxorubicin vincristine cyclophosphamide and rituximab will be progression free at one year
Eligibility
Aggressive B-lymphocyte antigen CD20 CD20 positive Diffuse large B cell lymphoma DLBCL
HIV serology
All stages I-IV of disease
Eastern Cooperative Oncology Group ECOG Performance status 0-4
Non-Hodgkins Lymphoma NHL previously untreated with cytotoxic chemotherapy
Age greater than or equal to 18 years
May not be pregnant or nursing
May not have received previous rituximab
Design
Participants will be treated every three weeks with a combination of EPOCH and rituximab for one cycle beyond complete remission CRcomplete response unconfirmed CRu by computed tomography CT scan of all detectable tumors for a minimum of three and maximum of six cycles Following cycle 2 CT positron emission tomography scans PET and bone marrow biopsies if initially positive will be performed
At the conclusion of the study we will estimate whether the number of cycles can be reduced using the paradigm If the cumulative number of participants to relapse exceeds 25 percent by 6 months the study will be closed
Following the completion of chemotherapy restaging will be performed 2 months following the end of treatment then every 3 months for one year every 6 months for one year then every 12 months until relapse death or loss to follow up
Antiretroviral therapy ART will be given concurrently with treatment regimen
To study the effects of treatment approach on parameters of HIV disease measurements of cluster of differentiation 4 CD4 cells and viral loads will be made at baseline and at the completion of therapy and then 2 months following the end of treatment and then every 3-6 months for a total of 24 months following chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-C-0030 | None | None | None |