Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00553501 |
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: epratuzumab Drug: fludeoxyglucose F 18 Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL) |
Estimated Enrollment: | 58 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients receive fludeoxyglucose F 18 (FDG) subcutaneously and undergo positron emission tomography at baseline and after induction therapy to assess the degree of FDG uptake.
After completion of study treatment, patients are followed every 4 months for 2 years then every 6 months for up to 10 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)
Measurable disease by physical examination or imaging studies
No nonmeasurable disease only, including any of the following:
PATIENT CHARACTERISTICS:
Patients with HIV infection are eligible provided they meet the following criteria:
PRIOR CONCURRENT THERAPY:
No concurrent dexamethasone or other steroids as antiemetics except for the following circumstances:
Study Chair: | Barbara W. Grant, MD | University of Vermont |
Study ID Numbers: | CDR0000572604, CALGB-50701 |
Study First Received: | November 2, 2007 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00553501 |
Health Authority: | Unspecified |
stage II grade 1 follicular lymphoma stage II grade 2 follicular lymphoma stage II grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma |
stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse |
Lymphoma, Follicular Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |