Rituximab in Treating Patients With Hodgkin's Lymphoma
Completed · Phase 2
Conditions studied: Lymphoma, Hodgkin Lymphoma (Category), Nodular Lymphocyte Predominant Hodgkin Lymphoma
In brief
Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.
Key facts
- Study ID
- NCT00003820
- Run by
- Ranjana Advani
- People needed
- 39
- Starts
- 1999-01-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2017-04-20
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University Medical Center — Stanford, California, United States
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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