Rituximab in Treating Patients With Hodgkin's Lymphoma

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

Detailed Description
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This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months. This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.

Official Title
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Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease

Conditions
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Lymphoma, Hodgkin Lymphoma (Category), Nodular Lymphocyte Predominant Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab 375 mg/m2 per week<br>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). | Drug: Rituximab<br>* Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.<br>* Other names: Zytux (biosimilar);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS, assessed as the number of patients 5 years after treatment who are alive | 5 years | 
| Overall Response Rate (ORR) | Overall response as assessed as Complete Response (CR) + Partial Response (PR) CR was determined as complete metabolic response (CMR), meaning complete resolution of 18-fluorodeoxyglucose (FDG) uptake within the tumor volume so that it is indistinguishable from surrounding normal tissue. PR was determined as partial metabolic response (PMR), meaning reduction of greater than 25% in the standardized uptake value (SUV) adjusted for body surface area (SUV-BSA). A reduction in the extent of tumor FDG uptake is not required for PMR. | 4 weeks |