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

Phase 2
3 Years
Not Enrolling
Lymphoma, Hodgkin Lymphoma (Category)

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Trial Information

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


- 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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival by Kaplan-Meie

Outcome Time Frame:

15 months

Safety Issue:


Principal Investigator

Ranjana Hira Advani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

January 1999

Completion Date:

August 2008

Related Keywords:

  • Lymphoma
  • Hodgkin Lymphoma (Category)
  • Hodgkin Disease
  • Lymphoma



Stanford University Medical Center Stanford, California  94305-5408
Stanford University School of Medicine Stanford, California  94305-5317