Know Cancer

or
forgot password

Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma Whose Disease Has Been Controlled With Chemotherapy: Rituximab Anti-CD20 Monoclonal Antibody or Interferon Alpha 2-b as Maintenance Therapy


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma Whose Disease Has Been Controlled With Chemotherapy: Rituximab Anti-CD20 Monoclonal Antibody or Interferon Alpha 2-b as Maintenance Therapy


OBJECTIVES: I. Determine the toxicity of rituximab or interferon alfa-2b maintenance therapy
in patients with chronic lymphocytic leukemia or multiple myeloma in remission after
chemotherapy. II. Determine the progression free survival, failure free survival, and
overall survival of these patients from time of chemotherapy discontinuation to completion
of maintenance therapy. III. Compare the survival rates of these patients to similar
patients treated in published studies. IV. Determine the quality of life of these patients
on these regimens.

OUTLINE: Patients enter one of two treatment arms: Arm I: Patients receive rituximab IV on
days 1, 8, 15, and 22 for course 1, and then once a month for 11 months or until disease
progression. Arm II: Patients receive subcutaneous interferon alfa-2b every other day three
times per week for 12 months. Quality of life is assessed monthly during therapy. Patients
are followed every 3 months for 1 year, and then annually for up to 5 years.

PROJECTED ACCRUAL: A total of 60-80 patients (30-40 per disease type) will be accrued for
this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: B-cell chronic lymphocytic leukemia or multiple myeloma in
remission that was previously treated with chemotherapy without disease progression

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Lymphocyte count less than 10,000/mm3 Hepatic: Not specified
Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective
contraception No active infection or other concurrent lifethreatening disease Medical
condition satisfactory for treatment with chemotherapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified

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:

CDR0000066763

NCT ID:

NCT00004040

Start Date:

June 1998

Completion Date:

June 1999

Related Keywords:

  • Leukemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Hoag Memorial Hospital PresbyterianNewport Beach, California  92658
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
St. Joseph Regional Cancer CenterBryan, Texas  77802