- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00760877
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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MG
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Belo Horizonte, MG, 브라질, 30130-100
- Novartis Investigative Site
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PR
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Curitiba, PR, 브라질, 80060-900
- Novartis Investigative Site
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RJ
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Rio de Janeiro, RJ, 브라질, 21941-913
- Novartis Investigative Site
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SP
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Campinas, SP, 브라질, 13083-970
- Novartis Investigative Site
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Sao Paulo, SP, 브라질, 05403-000
- Novartis Investigative Site
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Madrid, 스페인, 28006
- Novartis Investigative Site
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Madrid, 스페인, 28007
- Novartis Investigative Site
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Andalucia
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Malaga, Andalucia, 스페인, 29010
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, 스페인, 08036
- Novartis Investigative Site
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Navarra
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Pamplona, Navarra, 스페인, 31008
- Novartis Investigative Site
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Buenos Aires
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Caba, Buenos Aires, 아르헨티나, C1221ADH
- Novartis Investigative Site
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Novartis Investigative Site
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Ontario
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Hamilton, Ontario, 캐나다, L8H 4J9
- Novartis Investigative Site
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Toronto, Ontario, 캐나다, M5G 2M9
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, 캐나다, H1T 2M4
- Novartis Investigative Site
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Québec, Quebec, 캐나다, G1J 1Z4
- Novartis Investigative Site
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Bordeaux, 프랑스, 33076
- Novartis Investigative Site
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Creteil, 프랑스, 94010
- Novartis Investigative Site
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Lyon cedex 04, 프랑스, 69317
- Novartis Investigative Site
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Paris, 프랑스, 75010
- Novartis Investigative Site
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Vandoeuvre les Nancy, 프랑스, 54511
- Novartis Investigative Site
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New South Wales
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St. Leonards, New South Wales, 호주, 2065
- Novartis Investigative Site
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Westmead, New South Wales, 호주, 2145
- Novartis Investigative Site
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Queensland
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Herston, Queensland, 호주, 4029
- Novartis Investigative Site
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South Brisbane, Queensland, 호주, 4101
- Novartis Investigative Site
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Woolloongabba, Queensland, 호주, 4102
- Novartis Investigative Site
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South Australia
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Adelaide, South Australia, 호주, 5000
- Novartis Investigative Site
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Victoria
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Parkville, Victoria, 호주, 3050
- Novartis Investigative Site
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Prahran, Victoria, 호주, 3181
- Novartis Investigative Site
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Western Australia
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Nedlands, Western Australia, 호주, 6009
- Novartis Investigative Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months Persistent disease demonstrated by two PCR positive tests 3 months apart both during the past 6 months.
Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No other current or planned anti-leukemia therapies
Exclusion Criteria:
Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months) Patient has received another investigational agent within last 6 months or tyrosine kinase inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation
Impaired cardiac function including any one of the following:
Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known family history of long QT syndrome. Clinically significant resting brachycardia (<50 beats per minute) QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension) History of or presence of clinically significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Nilotinib
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
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Supplied in 200 mg capsules
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활성 비교기: Imatinib
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
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Supplied in 100 mg and 400 mg capsules
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)
기간: 12 months
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The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date.
Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders.
Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders.
The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rate of Confirmed Best Cumulative CMR
기간: 24 months, 36 month, 48 months
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The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date.
Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders.
Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders.
The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
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24 months, 36 month, 48 months
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Number of Cross-over Participants With CMR
기간: 24 months, 36 months, 48 months
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The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
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24 months, 36 months, 48 months
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Progression Free Survival (PFS)
기간: 48 months
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PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.
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48 months
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Event-free Survival
기간: 48 months
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Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.
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48 months
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Overall Survival
기간: 48 months
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Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.
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48 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CAMN107A2405
- 2009-012616-40 (EudraCT 번호)
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. .
CHRONIC MYELOGENOUS LEUKEMIA에 대한 임상 시험
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Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
Nilotinib에 대한 임상 시험
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Baylor College of Medicine모병만성 골수성 백혈병 | 만성 골수성 백혈병, BCR/ABL 양성, 관해 상태 | 차도의 만성 골수성 백혈병미국
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Asan Medical Center빼는
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Hospices Civils de Lyon완전한
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Hospices Civils de LyonNovartis알려지지 않은
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Medical College of WisconsinMemorial Sloan Kettering Cancer Center; Dana-Farber Cancer Institute; University of Chicago; Emory University 그리고 다른 협력자들완전한
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University of JenaNovartis Pharmaceuticals; Ludwig-Maximilians - University of Munich모집하지 않고 적극적으로