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Rituximab Anti-CD20 Monoclonal Antibody and Dexamethasone in the Treatment of Relapsed Indolent Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

Rituximab Anti-CD20 Monoclonal Antibody and Dexamethasone in the Treatment of Relapsed Indolent Lymphoma

OBJECTIVES: I. Determine the toxic effects of rituximab and dexamethasone in patients with
recurrent or refractory indolent non-Hodgkin's lymphoma. II. Determine the objective tumor
response rate and duration of response at 2 months after initiation of therapy, and the
percentage of patients with progressive disease. III. Determine the maximum response,
duration of response, and progression free interval for patients who have not progressed
after 4 weeks of therapy. IV. Determine the failure-free and overall survival of these
patients on this regimen. V. Compare the response rate and survival rates to results for
similar patients (historical and concurrent) who have received 4 weeks of rituximab without
dexamethasone, and patients who did not receive maintenance rituximab.

OUTLINE: Patients receive dexamethasone IV followed by rituximab IV on days 1, 8, 15, and 22
for one course. Two months after initiating treatment, patients are evaluated for disease
progression. Patients with stable or responding disease may receive monthly dexamethasone
and rituximab therapy for up to 10 additional months. Patients are followed every 3 months
for 2 years, then every 6 months for years 3-4, and then yearly for up to 5 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage III or IV, recurrent or refractory,
indolent B cell non-Hodgkin's lymphoma of the following types: Working Group Formulation A
(small cell lymphocytic) Working Group Formulation B, C, and D (follicular) Must have
relapsed after prior chemotherapy At least 1 lymph node or visceral lesion at least 2 cm
in diameter

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified
Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective
contraception No active infection HIV negative No hepatitis B or C No concurrent life
threatening condition

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy for
lymphoma (e.g., rituximab) Chemotherapy: See Disease Characteristics Endocrine therapy: No
other concurrent corticosteroids and/or epinephrine (unless anaphylactic shock)
Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Biotherapy Research Group


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

January 2000

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Hoag Memorial Hospital Presbyterian Newport Beach, California  92658
St. Joseph Regional Cancer Center Bryan, Texas  77802
Cancer Care Center for Southern Indiana Bloomington, Indiana  47403