Rituximab in Treating Patients With Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Ranjana Advani, Stanford University
ClinicalTrials.gov Identifier:
NCT00003820
First received: November 1, 1999
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Lymphoma
Hodgkin Lymphoma (Category)
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Progression-free survival by Kaplan-Meie [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rates by Kaplan-Meier [ Time Frame: 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: January 1999
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003820

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Ranjana Advani
Genentech
Investigators
Principal Investigator: Ranjana Hira Advani Stanford University
Principal Investigator: Richard T. Hoppe Stanford University
  More Information

No publications provided

Responsible Party: Ranjana Advani, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00003820     History of Changes
Other Study ID Numbers: LYMHD0003, 75967, U2082N
Study First Received: November 1, 1999
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 23, 2014