Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00003820
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT00003820
Study Brief:
Protocol Section:
NCT00003820