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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | July 1999 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003849 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Biological: rituximab | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Witzig TE, Vukov AM, Habermann TM, Geyer S, Kurtin PJ, Friedenberg WR, White WL, Chalchal HI, Flynn PJ, Fitch TR, Welker DA. Rituximab therapy for patients with newly diagnosed, advanced-stage, follicular grade I non-Hodgkin's lymphoma: a phase II trial in the North Central Cancer Treatment Group. J Clin Oncol. 2005 Feb 20;23(6):1103-8. Epub 2005 Jan 18. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 32 | ||||
| Completion Date | |||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003849 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067010, NCCTG-987851 | ||||
| Study Sponsor ICMJE | North Central Cancer Treatment Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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