- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00274976
Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
Subcutaneous Campath-1H in Fludarabine-Refractory CLL
RATIONALE: Monoclonal antibodies, such as alemtuzumab, 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.
PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in treating patients with advanced chronic lymphocytic leukemia that did not respond to previous fludarabine.
연구 개요
상세 설명
OBJECTIVES:
- Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab in patients with fludarabine-refractory advanced chronic lymphocytic leukemia.
- Determine the response in patients with high-risk genetic abnormalities (unmutated immunoglobulin variable heavy-chain [IgVH] status, del [17p], del [11q]) treated with subcutaneous alemtuzumab after progression on fludarabine.
OUTLINE: This is a multicenter study.
Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously once weekly for up to 12 weeks.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Ansbach, 독일, 91522
- Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
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Aschaffenburg, 독일, 63739
- Specialist Practice for Oncology
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Bad Saarow, 독일, 15526
- Humaine - Clinic
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Berlin, 독일, D-13122
- Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
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Berlin, 독일, 13357
- Haematolo-Onkologische Schwerpunktpraxis - Berlin
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Chemnitz, 독일, 09113
- Hospital Kuchwald Chemnitz
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Essen, 독일, D-45122
- Universitaetsklinikum Essen
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Esslingen, 독일, 73730
- Staedtische Kliniken Esslingen
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Frankfurt, 독일, D-60488
- Krankenhaus Nordwest
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Freiburg, 독일, D-79106
- Universitaetsklinikum Freiburg
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Goettingen, 독일, D-37075
- Universitaetsklinikum Goettingen
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Greifswald, 독일, D-17487
- Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
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Hagen, 독일, 58095
- St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
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Halle, 독일, 06110
- Internistische Gemeinschaftspraxis - Halle
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Hamburg, 독일, D-20099
- Asklepios Klinik St. Georg
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Hamburg, 독일, 22457
- Praxis fur Innere Medizin - Hamburg
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Hamm, 독일, DOH-59063
- Evangelische Krankenhaus Hamm
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Hannover, 독일, D-30625
- Medizinische Hochschule Hannover
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Heidelberg, 독일, D-69120
- Universitaets-Kinderklinik Heidelberg
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Herne, 독일, D-44625
- Marienhospital at Ruhr University Bochum
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Homburg, 독일, D-66421
- Universitaetsklinikum des Saarlandes
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Idar-Oberstein, 독일, D-55743
- Clinic for Bone Marrow Transplantation and Hematology and Oncology
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Kassel, 독일, 34117
- Internistische Gemeinschaftspraxis - Kassel
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Kiel, 독일, D-24105
- University Hospital Schleswig-Holstein - Kiel Campus
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Landshut, 독일, 84028
- Internistische Praxis - Landshut
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Lemgo, 독일, D-32657
- Klinikum Lippe - Lemgo
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Mannheim, 독일, D-68305
- III Medizinische Klinik Mannheim
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Munich, 독일, D-81675
- Klinikum Rechts der Isar - Technische Universitaet Muenchen
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Oldenburg, 독일, D-26133
- Klinikum Oldenburg
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Siegen, 독일, D-57072
- St. Marien - Krankenhaus Siegen GMBH
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Tuebingen, 독일, D-72076
- Southwest German Cancer Center at Eberhard-Karls-University
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Ulm, 독일, D-89081
- Universitaetsklinikum Ulm
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Wuerzburg, 독일, D-
- Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
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Wurzburg, 독일, 97070
- Hamatologisch - Onkologische Praxis Wurzburg
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Vienna, 오스트리아, A-1090
- Allgemeines Krankenhaus der Stadt Wien
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Confirmed diagnosis of previously treated advanced chronic lymphocytic leukemia (CLL)
- Fludarabine-refractory disease
- Requires treatment
PATIENT CHARACTERISTICS:
- Life expectancy more than 6 months
- ECOG 0-2
- No severe organ dysfunction
- No other concomitant or previous neoplasms
- No autoimmune hemolytic anemia or thrombocytopenia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Up to 5 prior chemotherapy regimens allowed
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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안전성과 효능
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응답
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공동 작업자 및 조사자
수사관
- Stephan Stilgenbauer, MD, Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
간행물 및 유용한 링크
일반 간행물
- Stilgenbauer S, Zenz T, Winkler D, Buhler A, Schlenk RF, Groner S, Busch R, Hensel M, Duhrsen U, Finke J, Dreger P, Jager U, Lengfelder E, Hohloch K, Soling U, Schlag R, Kneba M, Hallek M, Dohner H; German Chronic Lymphocytic Leukemia Study Group. Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2009 Aug 20;27(24):3994-4001. doi: 10.1200/JCO.2008.21.1128. Epub 2009 Jul 13.
- Zenz T, Habe S, Denzel T, Mohr J, Winkler D, Buhler A, Sarno A, Groner S, Mertens D, Busch R, Hallek M, Dohner H, Stilgenbauer S. Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contribution of 17p deletion, TP53 mutation, p53-p21 dysfunction, and miR34a in a prospective clinical trial. Blood. 2009 Sep 24;114(13):2589-97. doi: 10.1182/blood-2009-05-224071. Epub 2009 Jul 30.
- Stilgenbauer S, Zenz T, Winkler D, et al.: Subcutaneous alemtuzumab (Campath) in fludarabine-refractory CLL: final results of the CLL2H trial of the GCLLSG and comprehensive analysis of prognostic markers. [Abstract] Blood 112 (11): A-329, 2008.
- Schnaiter A, Paschka P, Rossi M, Zenz T, Buhler A, Winkler D, Cazzola M, Dohner K, Edelmann J, Mertens D, Kless S, Mack S, Busch R, Hallek M, Dohner H, Stilgenbauer S. NOTCH1, SF3B1, and TP53 mutations in fludarabine-refractory CLL patients treated with alemtuzumab: results from the CLL2H trial of the GCLLSG. Blood. 2013 Aug 15;122(7):1266-70. doi: 10.1182/blood-2013-03-488197. Epub 2013 Jul 2.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000455059
- GCLLSG-CLL2H
- EU-20550
- MEDAC-GCLLSG-CLL2H
- AMGEN-GCLLSG-CLL2H
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. .
알렘투주맙에 대한 임상 시험
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Genzyme, a Sanofi Company완전한
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Milton S. Hershey Medical Center종료됨