Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
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Purpose
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 |
Biological: epratuzumab Biological: rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
- Response rate [ Time Frame: 10 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
- Time to progression (TTP) [ Time Frame: up to 10 years from study entry ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | July 2019 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
-
Biological: epratuzumab
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| 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)
- 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
Contacts and Locations
Hide Study Locations| United States, California | |
| Kaiser Permanente Medical Office -Vandever Medical Office | |
| San Diego, California, United States, 92120 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Middlesex Hospital Cancer Center | |
| Middletown, Connecticut, United States, 06457 | |
| United States, Delaware | |
| Tunnell Cancer Center at Beebe Medical Center | |
| Lewes, Delaware, United States, 19958 | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Illinois | |
| University of Illinois Cancer Center | |
| Chicago, Illinois, United States, 60612-7243 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Fort Wayne Medical Oncology and Hematology | |
| Fort Wayne, Indiana, United States, 46845 | |
| Howard Community Hospital | |
| Kokomo, Indiana, United States, 46904 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| South Bend Clinic | |
| South Bend, Indiana, United States, 46617 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Saint Joseph Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Iowa | |
| Hematology Oncology Associates of the Quad Cities | |
| Bettendorf, Iowa, United States, 52722 | |
| United States, Maryland | |
| Union Hospital Cancer Program at Union Hospital | |
| Elkton MD, Maryland, United States, 21921 | |
| United States, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Oncology Care Associates, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| Lakeland Regional Cancer Care Center - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Hampshire | |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | |
| Concord, New Hampshire, United States, 03301 | |
| New Hampshire Oncology - Hematology, PA - Hooksett | |
| Hooksett, New Hampshire, United States, 03106 | |
| Lakes Region General Hospital | |
| Laconia, New Hampshire, United States, 03246 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| CCOP - Hematology-Oncology Associates of Central New York | |
| East Syracuse, New York, United States, 13057 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Kinston Medical Specialists | |
| Kinston, North Carolina, United States, 28501 | |
| Iredell Memorial Hospital | |
| Statesville, North Carolina, United States, 28677 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Vermont | |
| Mountainview Medical | |
| Berlin, Vermont, United States, 05602 | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | |
| Martinsville, Virginia, United States, 24115 | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, West Virginia | |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | |
| Huntington, West Virginia, United States, 25702 | |
| Study Chair: | Barbara W. Grant, MD | University of Vermont |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00553501 History of Changes |
| Other Study ID Numbers: | CDR0000572604, U10CA031946, CALGB-50701 |
| Study First Received: | November 2, 2007 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cancer and Leukemia Group B:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013