Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

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.
    

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 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.
    

Intervention name(s): Bleomycin; Rituximab; Dacarbazine; Doxorubicin; Vinblastine
Intervention type(s): Drug; Biological; Drug; Drug; Drug
Other intervention name(s): Blenoxane; Rituxan; DTIC; DTIC-Dome; Adriamycin; Velban; Alkaban
Intervention MeSH terms: Rituximab; Doxorubicin; Dacarbazine; Bleomycin; Vinblastine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma