Rituximab in Treating Patients With Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003820
• Other study ID #: LYMHD0003
• Secondary ID: 75967U2082N
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 5, 2012
• Start date: January 1999
• Est. completion date: August 2008

Study information

• Verified date: June 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Hodgkin's lymphoma.

Description:

OBJECTIVES:

• Determine the partial and complete response rates in patients with untreated or recurrent/refractory lymphocyte predominant Hodgkin's lymphoma treated with rituximab.

• Determine the efficacy of this regimen in terms of duration of disease free survival and time to progression in this patient population.

• Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive rituximab IV over several hours once a week for 4 weeks followed by maintenance rituximab at 6, 12, and 18 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:- Patients must have lymphocyte predominant Hodgkin's disease that is of B-cell lineage and expresses the CD 20 antigen. Patients are eligible with either untreated disease or refractory/relapsed disease.

• Patients must be >= 3 years.

• Patients must have a performance status of 0-2.

• Patients must have an ANC > 1500/ml and a platelet count > 50,000/ml.

• A biopsy or fine needle aspirate sample must show expression of the CD20 antigen on the L adnH cells.

• Patients must have measurable disease (at least one tumor mass measuring >1.0 cm in largest dimension).

• Patients must have no evidence of active infection.

• Patients must read and sign IRB approved informed consent.

• Adequate renal function as indicated by serum creatinine (Cr) < 1.5X the upper limit of normal.

• Adequate liver function as indicated by alkaline phosphatase, bilirubin, AST, and ALT < 2X upper limit of normal unless related to primary disease.

• Patients at high risk of HBV infection should be screened prior to enrollment.

Exclusion Criteria:- Concomitant or recent treatment with radiotherapy or chemotherapy. Four weeks must pass from radiotherapy or cytotoxic therapy to enroll (six weeks for nitrosourea compounds).

• Major surgery, other than diagnostic surgery, within 4 weeks.

• Female patients must be of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry.

• Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives.

• Treatment with an investigational drug within 30 days or 5 half-lives (of the study drug with the longest half-life) prior to entry into the study, whichever is longer.

• Evidence of other active malignancies other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin.

• Life expectancy<= 12 weeks.

• Concurrent treatment with prednisone or other systemic steroid medication.

• Active HBV infection or hepatitis.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma (Category)
• Lymphoma

Intervention

Drug:
• Rituximab
An initial course of rituximab at 375 mg/m2 weekly for 4 consecutive weeks. Patients who have an objective response or stable disease to the initial course will receive additional courses of rituximab treatment every six months for 4 courses.

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Ranjana Advani	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival by Kaplan-Meie		15 months	No
Secondary	Response rates by Kaplan-Meier		3, 6, 12, 18, and 24 months	No