Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369681
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2006-08-24
Brief Title:
Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II Stage III or Stage IV Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-07
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 patients with newly diagnosed stage II stage III or stage IV Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed stage II stage III or stage IV Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Investigate plasma DNA biomarkers including plasma clonal immunoglobulin DNA tumor suppressor gene methylation and Epstein-Barr virus DNA in patients receiving rituximab and doxorubicin hydrochloride bleomycin vinblastine and dacarbazine ABVD for newly diagnosed stage II-IV classical Hodgkins lymphoma
Characterize the impact of rituximab on these markers
Characterize the relationship between marker detection and clinical outcome
Secondary
Estimate the event-free survival of patients with newly diagnosed Hodgkins lymphoma treated with rituximab and ABVD
Assess the presence of Hodgkins lymphoma stem cells in peripheral blood mononuclear cells at baseline after treatment with rituximab and after treatment with ABVD
Assess whether plasma DNA biomarkers add information to fludeoxyglucose F 18 positron emission tomography FDG-PET in assessing tumor response
OUTLINE Patients receive doxorubicin hydrochloride IV vinblastine IV bleomycin IV and dacarbazine IV ABVD on days 1 and 15 of all courses Patients also receive rituximab IV on days -6 1 8 15 and 22 of ABVD course 1 and on day 1 only of ABVD courses 2 4 and 6 Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity
Patients with bulky disease may undergo radiotherapy
Plasma samples are obtained during treatment for investigation of tumor markers eg immunoglobulin rearrangement patterns of DNA methylation and the presence of Epstein-Barr virus DNA Patients undergo fludeoxyglucose F18 positron emission tomography periodically during the study
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Investigate plasma DNA biomarkers including plasma clonal immunoglobulin DNA tumor suppressor gene methylation and Epstein-Barr virus DNA in patients receiving rituximab and doxorubicin hydrochloride bleomycin vinblastine and dacarbazine ABVD for newly diagnosed stage II-IV classical Hodgkins lymphoma
Characterize the impact of rituximab on these markers
Characterize the relationship between marker detection and clinical outcome
Secondary
Estimate the event-free survival of patients with newly diagnosed Hodgkins lymphoma treated with rituximab and ABVD
Assess the presence of Hodgkins lymphoma stem cells in peripheral blood mononuclear cells at baseline after treatment with rituximab and after treatment with ABVD
Assess whether plasma DNA biomarkers add information to fludeoxyglucose F 18 positron emission tomography FDG-PET in assessing tumor response
OUTLINE Patients receive doxorubicin hydrochloride IV vinblastine IV bleomycin IV and dacarbazine IV ABVD on days 1 and 15 of all courses Patients also receive rituximab IV on days -6 1 8 15 and 22 of ABVD course 1 and on day 1 only of ABVD courses 2 4 and 6 Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity
Patients with bulky disease may undergo radiotherapy
Plasma samples are obtained during treatment for investigation of tumor markers eg immunoglobulin rearrangement patterns of DNA methylation and the presence of Epstein-Barr virus DNA Patients undergo fludeoxyglucose F18 positron emission tomography periodically during the study
PROJECTED ACCRUAL A total of 35 patients will be 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 |
|---|---|---|---|
| NA_00002473 | OTHER | Johns Hopkins Medicine IRB | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |