Rituximab in Treating Patients With Hodgkin's Lymphoma
Condition: Lymphoma; Hodgkin Lymphoma (Category); Nodular Lymphocyte Predominant Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Rituximab
Intervention description: Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No

Summary:

      Phase 2 trial to study the effectiveness of rituximab in treating patients who have
      lymphocyte-predominant Hodgkin's lymphoma.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Age ≥ 3 years

          -  Lymphocyte-predominant Hodgkin's disease (LPHD) of B-cell lineage

          -  Biopsy-confirmed expression of CD20 antigen

          -  At least one tumor mass measuring > 1.0 cm in largest dimension

          -  No evidence of active infection

          -  Subjects at high risk of Hepatitis B virus (HBV) infection should be screened prior to
             enrollment.

          -  Performance status of 0 to 2

          -  Absolute neutrophil count (ANC) > 1500/mL

          -  Platelet count > 50,000/mL

          -  Serum creatinine (Cr) < 1.5 x upper limit of normal (ULN)

          -  Alkaline phosphatase < 2 x ULN, unless related to primary disease

          -  Bilirubin < 2 x ULN, unless related to primary disease

          -  Aspartate transaminase (AST) and alanine transaminase (ALT) < 2 x ULN, unless related
             to primary disease

          -  Subjects must be able to read and sign Institutional Review Board-approved informed
             consent

        EXCLUSION CRITERIA

          -  Life expectancy at least 12 weeks

          -  Evidence of other active malignancies other than cured carcinomas in situ of the
             cervix or basal cell carcinoma of the skin

          -  Active HBV infection or hepatitis.

          -  Serious non-malignant disease (eg, congestive heart failure, or active uncontrolled
             bacterial, viral, or fungal infections)

          -  Concomitant or treatment within prior 4 weeks with radiotherapy or chemotherapy
             (within prior 6 weeks for nitrosourea compounds)

          -  Concurrent treatment with prednisone or other systemic steroid medication

          -  Treatment with any investigational drug within 30 days prior to entry into the study

          -  Treatment with any investigational drug within 5 half-lives of that drug prior to
             entry into the study

          -  Major surgery, other than diagnostic surgery, within 4 weeks

          -  Any other conditions which, in the opinion of the investigator and/or sponsor, would
             compromise other protocol objectives

          -  Female patients must be of non-childbearing potential or using adequate contraception
             with a negative pregnancy test at study entry