Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
NCT ID: NCT00553501
Last Updated: 2016-07-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2008-03-31
2014-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epratuzumab Plus Rituximab
Induction Therapy (Month 1): Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22
Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
epratuzumab
Days 1, 8, 15, 22 and weeks 12, 20, 28, \& 36: 360mg/sq m IV
rituximab
Day 3, 8, 15, 22 and weeks 12, 20, 28, \& 36: 375mg/sq m IV
Interventions
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epratuzumab
Days 1, 8, 15, 22 and weeks 12, 20, 28, \& 36: 360mg/sq m IV
rituximab
Day 3, 8, 15, 22 and weeks 12, 20, 28, \& 36: 375mg/sq m IV
Eligibility Criteria
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Inclusion Criteria
* CD4+ cell count ≥ 400/mm\^3
* No evidence of resistant strains of HIV
* If not on anti-HIV therapy, HIV viral load \< 10,000 copies HIV RNA/mL
* If on anti-HIV therapy, HIV viral load \< 50 copies HIV RNA/mL
* No history of AIDS-defining conditions
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* No known Human Anti-Chimeric Antibody (HACA)-positivity
PRIOR CONCURRENT THERAPY:
* No prior therapy for NHL including chemotherapy, radiotherapy, or immunotherapy (e.g., monoclonal antibody-based therapy)
* More than 2 weeks since prior corticosteroids except for maintenance therapy for non-malignant disease
* No concurrent dexamethasone or other steroids as antiemetics except for the following circumstances:
* Treatment of acute infusion reactions according to institutional procedures
* No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
* No other concurrent chemotherapeutic agents
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Barbara Grant, MD
Role: STUDY_CHAIR
University of Vermont
Locations
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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 D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., 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
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Oncology Care Associates, PLLC
Saint 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
St 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 Township, 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 Corners, 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
Countries
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References
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Grant BW, Jung SH, Johnson JL, Kostakoglu L, Hsi E, Byrd JC, Jones J, Leonard JP, Martin SE, Cheson BD. A phase 2 trial of extended induction epratuzumab and rituximab for previously untreated follicular lymphoma: CALGB 50701. Cancer. 2013 Nov 1;119(21):3797-804. doi: 10.1002/cncr.28299. Epub 2013 Aug 6.
Rutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5.
Lansigan F, Barak I, Pitcher B, Jung SH, Cheson BD, Czuczman M, Martin P, Hsi E, Schoder H, Smith S, Bartlett NL, Leonard JP, Blum KA. The prognostic significance of PFS24 in follicular lymphoma following firstline immunotherapy: A combined analysis of 3 CALGB trials. Cancer Med. 2019 Jan;8(1):165-173. doi: 10.1002/cam4.1918. Epub 2018 Dec 21.
Other Identifiers
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CALGB-50701
Identifier Type: -
Identifier Source: secondary_id
CDR0000572604
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-50701
Identifier Type: -
Identifier Source: org_study_id
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