A Phase II Trial of C2B8 in Patients With Asymptomatic CD20+ B-Cell Follicular Small Cleaved Low-Grade Non-Hodgkin's Lymphoma or Relapsed CD20+ Hodgkin's Disease
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Trial of C2B8 in Patients With Asymptomatic CD20+ B-Cell Follicular Small Cleaved Low-Grade Non-Hodgkin's Lymphoma or Relapsed CD20+ Hodgkin's Disease
OBJECTIVES: I. Determine the response rate (complete or partial) to rituximab in previously
untreated patients with stage III or IV CD20+ B-cell follicular small cleaved cell
non-Hodgkin's lymphoma. II. Determine the response rate (complete or partial) to rituximab
in patients with relapsed CD20+ Hodgkin's disease. III. Determine the time to progression
and time to chemotherapy in these patients after treatment with rituximab.
OUTLINE: Patients are stratified according to disease (follicular small cleaved cell
non-Hodgkin's lymphoma vs relapsed Hodgkin's disease). Patients receive rituximab IV over
4-6 hours on day 1 weekly for 4 weeks. Patients are followed at 1, 3, 6, 9, and 12 months,
then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 21-32 patients will be accrued for each arm of this study
within 7-10.5 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven stage IIIA or stage IVA B-cell follicular
small cleaved cell non-Hodgkin's lymphoma Tumor cells express CD20 No prior chemotherapy
or radiotherapy Stable disease that would otherwise be observed OR Histologically proven
relapsed Hodgkin's disease of any stage Tumor cells express CD20 Bidimensionally
measurable disease Masses (e.g., enlarged lymph nodes) must be at least 1.5 cm X 1.5 cm by
CT, MRI, or x-ray Splenic enlargement considered measurable if spleen palpable at least 3
cm below the left costal margin No CNS lymphoma
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: No more than 5,000 circulating tumor cells Hepatic: Not
specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use
effective contraception during and for at least 12 months following study HIV negative No
other active malignancies
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Thomas E. Witzig, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000067010
NCT ID:
NCT00003849
Start Date:
July 1999
Completion Date:
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- stage III grade 1 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CentraCare Clinic | Saint Cloud, Minnesota 56303 |
| Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| Altru Health Systems | Grand Forks, North Dakota 58201 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
