Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma
Condition: Classic Hodgkin Lymphoma; Lugano Classification Stage III Hodgkin Lymphoma AJCC v8; Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Bleomycin; Dacarbazine; Doxorubicin Hydrochloride; Rituximab; Vinblastine
Intervention description: Given IV; Given IV; Given IV; Given IV; Given IV
Intervention MeSH terms: Rituximab; Antineoplastic Agents, Immunological; Doxorubicin; Liposomal doxorubicin; Dacarbazine; Bleomycin; Vinblastine; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Imidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well combination chemotherapy with or without rituximab works
      in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies,
      such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs
      used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and
      dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab
      with combination chemotherapy may work better in treating participants with classic Hodgkin
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated patient with classical Hodgkin's lymphoma patients with stage III
             and IV

          -  International Prognostic Score of > 2 (patient must have > 2 of the following risk
             features: Male, >= 45 years of age, stage IV, albumin < 4, white blood cell count
             [WBC] >= 15, lymphocytes < 8% or < 600, hemoglobin [Hgb] < 10.5)

          -  Must sign a consent form

          -  Absolute neutrophil count (ANC) >= 1,500/microL

          -  Platelet > 100,000/microL

          -  Left ventricular ejection fraction (LVEF) >= 50% by multigated acquisition (MUGA) scan
             or echocardiogram

          -  Serum creatinine < 2 mg/dl

          -  Serum bilirubin < 2 mg/dl

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit
             of normal (ULN)

          -  Bi-dimensionally measurable disease

        Exclusion Criteria:

          -  Lymphocyte predominant Hodgkin's lymphoma

          -  Known human immunodeficiency virus (HIV) infection

          -  Pregnant women and women of child bearing age who are not practicing adequate
             contraception

          -  Prior chemotherapy or radiation therapy

          -  Severe pulmonary disease as judged by the principal investigator (PI) including
             chronic obstructive pulmonary disease (COPD) and asthma

          -  Active infection requiring treatment with intravenous therapy

          -  Presence of central nervous system (CNS) lymphoma

          -  Concomitant malignancies or previous malignancies within the last 5 years (exception
             made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma
             in situ of cervix)

          -  Active hepatitis B or C infection