Non Hodgkin Lymphoma Clinical Trial
Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma
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 Hodgkin's lymphoma.
Full 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 Hodgkin's 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 Hodgkin's lymphoma treated with rituximab and ABVD.
Assess the presence of Hodgkin's 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 (e.g., 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin's lymphoma
No lymphocyte-predominant histology
Stage II, III, or IV disease
Newly diagnosed disease
PATIENT CHARACTERISTICS:
Performance status 0-2
Creatinine < 2.0 mg/dL
Bilirubin < 5 mg/dL
Not pregnant or nursing
No HIV positivity
Hepatitis B surface antigen negative
No active concurrent malignancy except for superficial nonmelanoma skin cancer or cervical carcinoma in situ
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy for Hodgkin's lymphoma
Steroids allowed if medically required before chemotherapy initiation
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 4 Locations for this study
Duarte California, 91010, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21231, United States
Rochester Minnesota, 55905, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.