- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01832597
Efficacy and Safety Study of Bendamustine With or Without Rituximab in Chronic Lymphoproliferative Disorders
2013년 4월 12일 업데이트: Gruppo Italiano Studio Linfomi
A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, As Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders
The purpose of this study is collect and evaluate the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.
연구 개요
상태
완전한
정황
상세 설명
All patients who meet the criteria for inclusion will be included in the study.
A specific database will be created to collect the following information: personal data, medical history, histology related to the underlying disease, comorbidities, laboratory data, initial staging, data on the dosage and the number of cycles administered, the recorded toxicity data, the clinical response and the main events (relapse, progression, death, and cause of death).
These data will then be retrospectively examined in order to obtain information about the life-saving treatment.
연구 유형
관찰
등록 (실제)
109
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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CZ
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Cosenza, CZ, 이탈리아, 87100
- UO di Ematologia, S.O. Annunziata
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MO
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Modena, MO, 이탈리아, 41124
- Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Universita' di Modena e Reggio Emilia
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PA
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Palermo, PA, 이탈리아, 90127
- UO di Ematologia, AOUP Paolo Giaccone,
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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
샘플링 방법
확률 샘플
연구 인구
All patients with relapsed or refractory chronic lymphoproliferative disorders treated with Bendamustine +/- Rituximab
설명
Inclusion Criteria:
- patients with relapsed or refractory chronic lymphoproliferative disorders
- salvage treatment with Bendamustine +/- Rituximab
- age ≥ 18 years
Exclusion Criteria:
- previous treatment with Bendamustine
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Response Rate (ORR)
기간: At least 2 months after completion of therapy
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Evaluate the activity of Bendamustine +/- Rituximab in term of ORR
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At least 2 months after completion of therapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progression Free Survival (PFS) and Overall Survival (OS)
기간: From the date of frist treatment cycle until the date of first documented progression or date of death for any cause, whichever came first, assessed up to 150 months
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Evaluate the activity of Bendamustine +/- Rituximab in term of PFS and OS
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From the date of frist treatment cycle until the date of first documented progression or date of death for any cause, whichever came first, assessed up to 150 months
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Number of Adverse Events
기간: From the date of first tratment cycle until 6 months after the date of last treatment cycle
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Assess to efficacy of Bendamustine +/- Rituximab in term of grade III and IV National Cancer Institute Common Toxicity Criteria (NCI CTC) adverse events
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From the date of first tratment cycle until 6 months after the date of last treatment cycle
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Stefano Luminari, MD, Gruppi Italiano Studi Linfomi
- 수석 연구원: Emilio Iannitto, MD, Gruppo Italiano Studio Linfomi
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
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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
2010년 11월 1일
기본 완료 (실제)
2010년 12월 1일
연구 완료 (실제)
2011년 1월 1일
연구 등록 날짜
최초 제출
2013년 4월 8일
QC 기준을 충족하는 최초 제출
2013년 4월 12일
처음 게시됨 (추정)
2013년 4월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 4월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 4월 12일
마지막으로 확인됨
2013년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RetroBENDA
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. .
만성림프구성백혈병에 대한 임상 시험
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Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인