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

NCT00553501 | Completed Phase 2 Results

• 3 other identifiers: CALGB-50701U10CA031946CDR0000572604
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 43

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Response

  Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: \>=50% decrease in the sum of the product of diameters of indicator lesions

  12 months

Secondary Outcomes (1)

• Progression Free Survival

  Duration of study (up to 10 years)

Study Arms (1)

Epratuzumab Plus Rituximab

EXPERIMENTAL

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

Biological: epratuzumab; Biological: rituximab

Interventions

epratuzumab BIOLOGICAL

Days 1, 8, 15, 22 and weeks 12, 20, 28, \& 36: 360mg/sq m IV

Epratuzumab Plus Rituximab

rituximab BIOLOGICAL

Day 3, 8, 15, 22 and weeks 12, 20, 28, \& 36: 375mg/sq m IV

Epratuzumab Plus Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically\* confirmed follicular non-Hodgkin lymphoma (NHL) * Previously untreated disease * WHO classification grade 1, 2, or 3a (\> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease NOTE: \*Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine-needle aspirates are not acceptable for diagnosis * Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry * Measurable disease by physical examination or imaging studies * Any tumor mass \> 1 cm is acceptable * No nonmeasurable disease only, including any of the following: * Bone lesions * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Bone marrow (involvement by NHL should be noted) * No known CNS involvement by lymphoma * Required to participate in companion FDG-PET imaging study CALGB 580701 PATIENT CHARACTERISTICS: * ECOG performance status ≤ 2 * Absolute neutrophil count ≥ 1,000/μL * Platelet count ≥ 50,000/μL * Patients with HIV infection are eligible provided they meet the following criteria: * No evidence of coinfection with hepatitis B or C * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (43)

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, 92120, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Middlesex Hospital Cancer Center

Middletown, Connecticut, 06457, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46845, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Oncology Care Associates, PLLC

Saint Joseph, Michigan, 49085, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

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

Concord, New Hampshire, 03301, United States

Location

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

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

Columbus, Ohio, 43210-1240, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Martinsville, Virginia, 24115, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

St. Mary's Regional Cancer Center at St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

Related Publications (3)

• 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.

  PMID: 23922187 RESULT

• 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.

  PMID: 35787017 DERIVED

• 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.

  PMID: 30575311 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

epratuzumab; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Barbara Grant, MD
• Organization: University of Vermont, Vermont Cancer Center

barbara.grant@vtmednet.org

Study Officials

• Barbara Grant, MD

  University of Vermont

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: March 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2014
• Last Updated: July 6, 2016
• Results First Posted: July 24, 2014

Record last verified: 2016-07

Locations

US (43)