Rituximab in Treating Patients With Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ranjana Advani
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

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