Rituximab in Treating Patients With Hodgkin's Lymphoma
Lymphoma, Hodgkin Lymphoma (Category), Nodular Lymphocyte Predominant Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Stanford University Medical Center
- Stanford University School of Medicine
Arms of the Study
Arm 1
Experimental
Rituximab 375 mg/m2 per week
375 mg/m2 rituximab by IV infusion weekly. The initial course of treatment is 4 weeks. Subjects who achieve an objective response or stable disease after the initial course (4 weeks) were permitted to continue additional 4-week cycles of treatment, for 3 additional courses starting every 6 months (ie, at 6; 12; and 18 months).