Rituximab in Treating Patients With Hodgkin's Lymphoma (NCT00003820) | Clinical Trial Compass
CompletedPhase 2
Rituximab in Treating Patients With Hodgkin's Lymphoma
United States39 participantsStarted 1999-01
Plain-language summary
Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.