Clinical trial · Interventional
Rituximab in Treating Patients With Hodgkin's Lymphoma
Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease
NCT00003820CI-TRIAL-00027087completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma (Category) | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Nodular Lymphocyte Predominant Hodgkin Lymphoma | Nodular Lymphocyte Predominant B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab 375 mg/m2 per week
- description
- 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).
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- 5 years
- description
- PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAdvani RH, Horning SJ, Hoppe RT, Daadi S, Allen J, Natkunam Y, Bartlett NL. Mature results of a phase II study of rituximab therapy for nodular lymphocyte-predominant Hodgkin lymphoma. J Clin Oncol. 2014 Mar 20;32(9):912-8. doi: 10.1200/JCO.2013.53.2069. Epub 2014 Feb 10. PMID 24516013
- RESULTHorning SJ, Bartlett NL, Breslin S, et al. Results of a prospective phase II trial of limited and extended rituximab treatment in nodular lymphocyte predominant Hodgkin's disease (NLPHD). Blood [ASH Annual Meeting Abstracts]. 2007;110:abs644.