Rituximab in Treating Patients With Hodgkin's Lymphoma

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

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

This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months.

This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.

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