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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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District of Columbia
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Washington、District of Columbia、アメリカ、20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Florida
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Fort Lauderdale、Florida、アメリカ、33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Hollywood、Florida、アメリカ、33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jupiter、Florida、アメリカ、33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach、Florida、アメリカ、33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Canton、Illinois、アメリカ、61520
- Graham Hospital
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Carthage、Illinois、アメリカ、62321
- Memorial Hospital
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Chicago、Illinois、アメリカ、60637-1470
- University of Chicago Cancer Research Center
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Eureka、Illinois、アメリカ、61530
- Eureka Community Hospital
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Galesburg、Illinois、アメリカ、61401
- Galesburg Cottage Hospital
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Galesburg、Illinois、アメリカ、61401
- Galesburg Clinic
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Havana、Illinois、アメリカ、62644
- Mason District Hospital
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Hopedale、Illinois、アメリカ、61747
- Hopedale Medical Complex
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Kewanee、Illinois、アメリカ、61443
- Kewanee Hospital
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Macomb、Illinois、アメリカ、61455
- Mcdonough District Hospital
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Normal、Illinois、アメリカ、61761
- Bromenn Regional Medical Center
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Normal、Illinois、アメリカ、61761
- Community Cancer Center
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Ottawa、Illinois、アメリカ、61350
- Community Hospital of Ottawa
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Ottawa、Illinois、アメリカ、61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin、Illinois、アメリカ、61554
- Cancer Treatment Center at Pekin Hospital
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Peoria、Illinois、アメリカ、61636
- Methodist Medical Center of Illinois
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Peoria、Illinois、アメリカ、61614
- Proctor Hospital
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Peoria、Illinois、アメリカ、61615
- CCOP - Illinois Oncology Research Association
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Peoria、Illinois、アメリカ、61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru、Illinois、アメリカ、61354
- Illinois Valley Community Hospital
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Princeton、Illinois、アメリカ、61356
- Perry Memorial Hospital
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Spring Valley、Illinois、アメリカ、61362
- St. Margaret's Hospital
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Indiana
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Fort Wayne、Indiana、アメリカ、46815
- Fort Wayne Medical Oncology and Hematology
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Iowa
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Cedar Rapids、Iowa、アメリカ、52402
- St. Luke's Hospital
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Cedar Rapids、Iowa、アメリカ、52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Cedar Rapids、Iowa、アメリカ、52402
- Iowa Blood and Cancer Care
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Iowa City、Iowa、アメリカ、52242
- Holden Comprehensive Cancer Center at University of Iowa
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Maine
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Bangor、Maine、アメリカ、04401
- CancerCare of Maine at Eastern Maine Medial Center
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Massachusetts
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Worcester、Massachusetts、アメリカ、01655
- UMASS Memorial Cancer Center - University Campus
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Minnesota
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Minneapolis、Minnesota、アメリカ、55417
- Veterans Affairs Medical Center - Minneapolis
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Missouri
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Columbia、Missouri、アメリカ、65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Jefferson City、Missouri、アメリカ、65101
- Capital Region Cancer Center
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St Louis、Missouri、アメリカ、63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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St. Louis、Missouri、アメリカ、63131
- Missouri Baptist Cancer Center
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New Hampshire
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Hooksett、New Hampshire、アメリカ、03106
- New Hampshire Oncology-Hematology, PA - Hooksett
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Keene、New Hampshire、アメリカ、03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
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Lebanon、New Hampshire、アメリカ、03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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Manchester、New Hampshire、アメリカ、03103
- Elliot Regional Cancer Center
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Rochester、New Hampshire、アメリカ、03867
- Frisbie Memorial Hospital
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New York
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Buffalo、New York、アメリカ、14263-0001
- Roswell Park Cancer Institute
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Glens Falls、New York、アメリカ、12801
- Charles R. Wood Cancer Center at Glens Falls Hospital
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New Hyde Park、New York、アメリカ、11042
- Long Island Jewish Medical Center
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New York、New York、アメリカ、10021
- Memorial Sloan-Kettering Cancer Center
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New York、New York、アメリカ、10021
- New York Weill Cornell Cancer Center at Cornell University
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Syracuse、New York、アメリカ、13215
- Community General Hospital of Greater Syracuse
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Syracuse、New York、アメリカ、13057
- CCOP - Hematology-Oncology Associates of Central New York
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North Carolina
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Gastonia、North Carolina、アメリカ、28053
- CaroMont Cancer Center at Gaston Memorial Hospital
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Goldsboro、North Carolina、アメリカ、27534
- Wayne Radiation Oncology
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Goldsboro、North Carolina、アメリカ、27534
- Wayne Memorial Hospital, Incorporated
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Hendersonville、North Carolina、アメリカ、28791
- Pardee Memorial Hospital
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Kinston、North Carolina、アメリカ、28501
- Lenoir Memorial Cancer Center
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Wilson、North Carolina、アメリカ、27893-3428
- Wilson Medical Center
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Winston-Salem、North Carolina、アメリカ、27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Columbus、Ohio、アメリカ、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、アメリカ、15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
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South Carolina
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Florence、South Carolina、アメリカ、29501
- McLeod Regional Medical Center
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Greenville、South Carolina、アメリカ、29615
- CCOP - Greenville
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Greenville、South Carolina、アメリカ、29601
- Bon Secours St. Francis Health System
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Vermont
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Berlin、Vermont、アメリカ、05602
- Mountainview Medical
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Burlington、Vermont、アメリカ、05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Danville、Virginia、アメリカ、24541
- Danville Regional Medical Center
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Martinsville、Virginia、アメリカ、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、アメリカ、25702
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall response
時間枠:12 months
|
complete and partial response will be assessed
|
12 months
|
協力者と研究者
捜査官
- スタディチェア:Myron S. Czuczman, MD、Roswell Park Cancer Institute
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CALGB-50402
- U10CA031946 (米国 NIH グラント/契約)
- CDR0000433340 (レジストリ識別子:NCI Physician Data Query)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
リツキシマブの臨床試験
-
Aprea Therapeutics終了しましたマントル細胞リンパ腫 | 慢性リンパ性白血病 | 非ホジキンリンパ腫アメリカ