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Spots Global Cancer Trial Database for Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

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Trial Identification

Brief Title: Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

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)

Study ID: NCT00553501

Conditions

Lymphoma

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: Primary * To determine the response rate (overall and complete) after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular non-Hodgkin lymphoma (NHL). * To determine the time to progression after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL. Secondary * To determine the toxicity profile of epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL. * To establish whether the therapeutic effects of the combination of epratuzumab and rituximab are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone). * To determine the relationship between the change in fludeoxyglucose F 18 uptake early after epratuzumab and rituximab treatment with response rate and time to progression. OUTLINE: * Induction therapy (month 1): Patients receive epratuzumab IV over 5-30 minutes on days 1, 8, 15, and 22 and rituximab IV on days 3, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity. * Extended induction therapy (months 3, 5, 7, and 9): Patients receive epratuzumab IV over 5-30 minutes followed by rituximab IV in weeks 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Kaiser Permanente Medical Office -Vandever Medical Office, San Diego, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

Middlesex Hospital Cancer Center, Middletown, Connecticut, United States

Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States

CCOP - Christiana Care Health Services, Newark, Delaware, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States

Walter Reed Army Medical Center, Washington, District of Columbia, United States

University of Illinois Cancer Center, Chicago, Illinois, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Elkhart General Hospital, Elkhart, Indiana, United States

Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States

Howard Community Hospital, Kokomo, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States

Memorial Hospital of South Bend, South Bend, Indiana, United States

Saint Joseph Regional Medical Center, South Bend, Indiana, United States

South Bend Clinic, South Bend, Indiana, United States

Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States

Union Hospital Cancer Program at Union Hospital, Elkton MD, Maryland, United States

Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

Oncology Care Associates, PLLC, Saint Joseph, Michigan, United States

Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care, Concord, New Hampshire, United States

New Hampshire Oncology - Hematology, PA - Hooksett, Hooksett, New Hampshire, United States

Lakes Region General Hospital, Laconia, New Hampshire, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States

New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

Kinston Medical Specialists, Kinston, North Carolina, United States

Iredell Memorial Hospital, Statesville, North Carolina, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States

Mountainview Medical, Berlin, Vermont, United States

Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States

Danville Regional Medical Center, Danville, Virginia, United States

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia, United States

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States

St. Mary's Regional Cancer Center at St. Mary's Medical Center, Huntington, West Virginia, United States

Contact Details

Name: Barbara Grant, MD

Affiliation: University of Vermont

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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