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Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma


OBJECTIVES: I. Determine the toxicity associated with cyclophosphamide and rituximab
(IDEC-C2B8 monoclonal antibody) as first line treatment in patients with stage III or IV
indolent B-cell lymphoma. II. Determine the objective tumor response rate and duration of
response associated with this first line treatment in these patients. III. Determine the
failure-free and overall survival for these patients. IV. Compare the response rate and
survival rates for patients with indolent lymphoma who were treated with this treatment as
the first systemic therapy for their disease with response rates and survival observed for
similar patients treated in published trials. V. Determine the quality of life associated
with this treatment in this patient population.

OUTLINE: This is an open label study. Patients receive oral cyclophosphamide daily and
rituximab (IDEC-C2B8 monoclonal antibody) IV on days 1, 8, 15, and 22 for the first 4-week
course. Patients then receive oral cyclophosphamide daily and rituximab IV monthly until 2
months beyond maximum response. Patients are treated for at least 6 months but no more than
18 months in the absence of disease progression. Patients are followed every 3 months for 2
years, then every 6 months for the next 2 years, and then annually for up to 10 years.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV indolent B-cell lymphoma
Diffuse small cleaved cell lymphoma Follicular small cleaved cell lymphoma Follicular
mixed cell lymphoma Follicular large cell lymphoma At least 1 lymph node or visceral
lesion at least 2 cm in diameter

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified
Renal: Not specified Other: No active infection No concurrent life threatening disease Not
pregnant Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Biotherapy Research Group

Authority:

United States: Federal Government

Study ID:

CDR0000066680

NCT ID:

NCT00003605

Start Date:

May 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 III adult diffuse small cleaved cell lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell 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

Name

Location

Hoag Memorial Hospital PresbyterianNewport Beach, California  92658
Bloomington HospitalBloomington, Indiana  47402
St. Joseph Regional Cancer CenterBryan, Texas  77802