NCT Number: NCT00003849
Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Saskatchewan Cancer Agency, Regina, Saskatchewan, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
response rate
Time frame: Up to 5 years
Secondary outcomes
-
time to progression
Time frame: Up to 5 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
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
Important dates
- Study start
- 1999
- Primary completion
- 2005
- Study completion
- 2008
- First posted
- May 3, 2004
- Registry last updated
- Jul 13, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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