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Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma


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

Thank you

Trial Information

Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma


OBJECTIVES: I. Determine the toxicity of cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV
high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor
response rate and duration of response for these regimens in these patients. III. Determine
the failure free survival and overall survival for these patients on these regimens. IV.
Compare the response rate and survival rate of these patients on these regimens to similar
patients treated in published studies. V. Compare the toxicities of these regimens in these
patients. VI. Determine the quality of life of these patients on these regimens.

OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms:
Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive
interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28
days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients
are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for
up to 10 years.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for
this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed high risk (stage III or IV) indolent or
intermediate (stage II to IV) B-cell lymphoma Small cleaved cell lymphoma Waldenstrom's
macroglobulinemia Follicular small cleaved cell or mixed cell Follicular large cell
Diffuse Immunoblastic High risk is defined as: Increased LDH OR Increased
beta-2-microglobulin OR B symptoms OR Bulky disease of greater than 7 cm in diameter OR
Extranodal disease other than blood or bone marrow involvement OR Mantle zone histology 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: Not specified Hepatic: Not specified Renal: Not specified
Other: No active infection or other medical condition this is lifethreatening Not pregnant
Fertile patients must use effective contraception

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:

CDR0000066762

NCT ID:

NCT00004039

Start Date:

June 1998

Completion Date:

January 2000

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • stage II grade 3 follicular lymphoma
  • stage II adult diffuse small cleaved cell lymphoma
  • stage II adult diffuse mixed cell lymphoma
  • stage II adult diffuse large cell lymphoma
  • stage II adult immunoblastic large cell lymphoma
  • stage II adult Burkitt lymphoma
  • 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 III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult Burkitt 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 IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult Burkitt lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Hoag Memorial Hospital PresbyterianNewport Beach, California  92658