- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00117975
Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #12373) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, 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 more than one monoclonal antibody may be a better way to block cancer growth.
PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the overall and complete response rate in patients with previously untreated CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma treated with rituximab and galiximab.
- Determine the time to disease progression in patients treated with this regimen.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Correlate Fc receptor polymorphism profiling with response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and galiximab IV over 1 hour on day 3, 8, 15, and 22.
- Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 4 months for up to 10 years.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Hollywood, Florida, United States, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jupiter, Florida, United States, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Canton, Illinois, United States, 61520
- Graham Hospital
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Carthage, Illinois, United States, 62321
- Memorial Hospital
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Eureka, Illinois, United States, 61530
- Eureka Community Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Clinic
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Havana, Illinois, United States, 62644
- Mason District Hospital
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Hopedale, Illinois, United States, 61747
- Hopedale Medical Complex
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Kewanee, Illinois, United States, 61443
- Kewanee Hospital
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Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
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Normal, Illinois, United States, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, United States, 61761
- Community Cancer Center
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Ottawa, Illinois, United States, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, United States, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, United States, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, United States, 61614
- Proctor Hospital
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Peoria, Illinois, United States, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, United States, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, United States, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, United States, 61362
- St. Margaret's Hospital
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Indiana
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Fort Wayne, Indiana, United States, 46815
- Fort Wayne Medical Oncology and Hematology
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Iowa
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Cedar Rapids, Iowa, United States, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, United States, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Cedar Rapids, Iowa, United States, 52402
- Iowa Blood and Cancer Care
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Iowa City, Iowa, United States, 52242
- Holden Comprehensive Cancer Center at University of Iowa
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Maine
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Bangor, Maine, United States, 04401
- CancerCare of Maine at Eastern Maine Medial Center
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- UMASS Memorial Cancer Center - University Campus
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Jefferson City, Missouri, United States, 65101
- Capital Region Cancer Center
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St Louis, Missouri, United States, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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St. Louis, Missouri, United States, 63131
- Missouri Baptist Cancer Center
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New Hampshire
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Hooksett, New Hampshire, United States, 03106
- New Hampshire Oncology-Hematology, PA - Hooksett
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Keene, New Hampshire, United States, 03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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Manchester, New Hampshire, United States, 03103
- Elliot Regional Cancer Center
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Rochester, New Hampshire, United States, 03867
- Frisbie Memorial Hospital
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Glens Falls, New York, United States, 12801
- Charles R. Wood Cancer Center at Glens Falls Hospital
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New Hyde Park, New York, United States, 11042
- Long Island Jewish Medical Center
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10021
- New York Weill Cornell Cancer Center at Cornell University
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Syracuse, New York, United States, 13215
- Community General Hospital of Greater Syracuse
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Syracuse, New York, United States, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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North Carolina
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Gastonia, North Carolina, United States, 28053
- CaroMont Cancer Center at Gaston Memorial Hospital
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Goldsboro, North Carolina, United States, 27534
- Wayne Radiation Oncology
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Goldsboro, North Carolina, United States, 27534
- Wayne Memorial Hospital, Incorporated
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Hendersonville, North Carolina, United States, 28791
- Pardee Memorial Hospital
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Kinston, North Carolina, United States, 28501
- Lenoir Memorial Cancer Center
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Wilson, North Carolina, United States, 27893-3428
- Wilson Medical Center
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Winston-Salem, North Carolina, United States, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
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South Carolina
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Florence, South Carolina, United States, 29501
- McLeod Regional Medical Center
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Greenville, South Carolina, United States, 29601
- Bon Secours St. Francis Health System
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Vermont
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Berlin, Vermont, United States, 05602
- Mountainview Medical
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Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Danville, Virginia, United States, 24541
- Danville Regional Medical Center
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Martinsville, Virginia, United States, 24115
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
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West Virginia
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Huntington, West Virginia, United States, 25702
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Documentation of Disease
1.1 Previously untreated, histologically confirmed follicular lymphoma, WHO classification, grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) which is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II.
1.1.1 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.
1.1.2 Failure to submit pathology specimens within 60 days of patient registration will result in the patient being declared ineligible.
1.2 Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression.
1.3 Patients classified as high risk according to the Follicular Lymphoma International Prognostic Index (FLIPI) should be considered for CALGB 50102/SWOG S0016 (A Phase III Trial of CHOP vs CHOP + Rituximab vs CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody [Tositumomab] For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas).
Prior Treatment
2.1 No prior therapy for non-Hodgkin lymphoma including chemotherapy, radiation or immunotherapy (e.g., monoclonal antibody-based therapy)
2.2 No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease
- Age - Patients must be ≥ 18 years of age
- ECOG Performance Status - Patients must have ECOG Performance Status 0-2.
Measurable Disease - Measurable disease must be present either on physical examination or imaging studies.
5.1 Non-measurable disease alone is not acceptable.
5.2 Any tumor mass > 1 cm is acceptable.
5.3 Lesions that are considered non-measurable include the following:
- Bone lesions (lesions if present should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow (involvement by non-Hodgkin lymphoma should be noted).
- CNS Involvement - Patients must have no known CNS involvement by lymphoma.
HIV Infection - Patients must have no known HIV infection.
7.1 Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus.
7.2 Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk.
- Human Anti-Chimeric Antibody - Patients must have no known baseline human anti-chimeric antibody (HACA) positivity.
Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing.
9.1 Due to the unknown teratogenic potential of galiximab, pregnant or nursing patients may not be enrolled.
9.2 Women and men of reproductive potential should agree to use an effective means of birth control throughout their participation in this study.
9.3 Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom).
Second Malignancy - Patients with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible.
10.1 This includes Waldenstrom's Macroglobulinemia, since such patients have experienced transient increases in IgM following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis.
10.2 Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse.
Required Initial Laboratory Values:
- ANC ≥ 1000/µL
- Platelet Count ≥ 50,000/µL
- Creatinine ≤ 2 x ULN Unless attributable to lymphoma
- Total Bilirubin ≤ 2 x ULN*† Unless attributable to Gilbert's disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response
Time Frame: 12 months
|
complete and partial response will be assessed
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Myron S. Czuczman, MD, Roswell Park Cancer Institute
Publications and helpful links
General Publications
- 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.
- Czuczman MS, Leonard JP, Johnson JL, et al.: FLIPI score is applicable and predictive of response to upfront immunotherapy in CALGB 50402: phase II trial of extended induction galiximab ([G] anti-CD80 monoclonal antibody) plus rituximab [R]. [Abstract] Blood 112 (11): A-1003, 2008.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV 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
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
- Galiximab
Other Study ID Numbers
- CALGB-50402
- U10CA031946 (U.S. NIH Grant/Contract)
- CDR0000433340 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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