Rituximab in Treating Patients With Hodgkin's Lymphoma

Not Recruiting

Trial ID: NCT00003820


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

Official Title

Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease

Stanford Investigator(s)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology



   - 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

   - 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


   - 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


drug: Rituximab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sarah Daadi

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