Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
2016년 7월 1일 업데이트: Alliance for Clinical Trials in Oncology
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)
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
60
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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San Diego, California, 미국, 92120
- Kaiser Permanente Medical Office -Vandever Medical Office
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San Francisco, California, 미국, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Connecticut
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Middletown, Connecticut, 미국, 06457
- Middlesex Hospital Cancer Center
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Delaware
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Lewes, Delaware, 미국, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, 미국, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, 미국, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, 미국, 20307-5001
- Walter Reed Army Medical Center
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Illinois
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Chicago, Illinois, 미국, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, 미국, 60612-7243
- University of Illinois Cancer Center
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Indiana
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Elkhart, Indiana, 미국, 46515
- Elkhart General Hospital
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Fort Wayne, Indiana, 미국, 46845
- Fort Wayne Medical Oncology and Hematology
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Kokomo, Indiana, 미국, 46904
- Howard Community Hospital
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La Porte, Indiana, 미국, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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South Bend, Indiana, 미국, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, 미국, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, 미국, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, 미국, 46617
- South Bend Clinic
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Iowa
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Bettendorf, Iowa, 미국, 52722
- Hematology Oncology Associates of the Quad Cities
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Maryland
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Elkton MD, Maryland, 미국, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, 미국, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Michigan
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Saint Joseph, Michigan, 미국, 49085
- Oncology Care Associates, PLLC
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St. Joseph, Michigan, 미국, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Missouri
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Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Saint Louis, Missouri, 미국, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Hampshire
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Concord, New Hampshire, 미국, 03301
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
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Hooksett, New Hampshire, 미국, 03106
- New Hampshire Oncology - Hematology, PA - Hooksett
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Laconia, New Hampshire, 미국, 03246
- Lakes Region General Hospital
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Lebanon, New Hampshire, 미국, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Voorhees, New Jersey, 미국, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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East Syracuse, New York, 미국, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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New York, New York, 미국, 10021
- New York Weill Cornell Cancer Center at Cornell University
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North Carolina
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Goldsboro, North Carolina, 미국, 27534
- Wayne Memorial Hospital, Incorporated
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Kinston, North Carolina, 미국, 28501
- Kinston Medical Specialists
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Statesville, North Carolina, 미국, 28677
- Iredell Memorial Hospital
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Winston-Salem, North Carolina, 미국, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Columbus, Ohio, 미국, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Vermont
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Berlin, Vermont, 미국, 05602
- Mountainview Medical
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Burlington, Vermont, 미국, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Danville, Virginia, 미국, 24541
- Danville Regional Medical Center
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Martinsville, Virginia, 미국, 24115
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
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Richmond, Virginia, 미국, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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West Virginia
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Huntington, West Virginia, 미국, 25702
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
Days 1, 8, 15, 22 and weeks 12, 20, 28, & 36: 360mg/sq m IV
Day 3, 8, 15, 22 and weeks 12, 20, 28, & 36: 375mg/sq m IV
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Overall Response
기간: 12 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression Free Survival
기간: Duration of study (up to 10 years)
|
Progression free survival (PFS) was defined as the time from registration to progression or death of any cause.
Progression free and alive patients were censored at the date of last follow-up.
The median PFS with 95% CI was estimated using the Kaplan Meier method.
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Duration of study (up to 10 years)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Barbara Grant, MD, University of Vermont
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 3월 1일
기본 완료 (실제)
2010년 7월 1일
연구 완료 (실제)
2014년 7월 1일
연구 등록 날짜
최초 제출
2007년 11월 2일
QC 기준을 충족하는 최초 제출
2007년 11월 2일
처음 게시됨 (추정)
2007년 11월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 7월 1일
마지막으로 확인됨
2016년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CALGB-50701
- U10CA031946 (미국 NIH 보조금/계약)
- CDR0000572604 (레지스트리 식별자: NCI Physician Data Query)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .