1차 만성 림프구성 백혈병(1L CLL)에 대해 공유 브루톤 티로신 키나제 억제제(cBTKi)를 투여받은 참가자에 대한 베네토클락스의 효과를 평가하여 치료 중단 기간을 허용하는 깊은 지속 완화를 달성하기 위한 연구 (BRAVE)
1L CLL에 대해 공유 BTKi를 사용하는 환자에게 Venetoclax를 추가하면 치료 중단 기간을 허용하기 위해 깊은 지속성 완화(UMRD 10^-4 기준)를 달성할 수 있는지 평가하기 위한 공개 라벨, 전향적 단일군, 다기관 임상 시험 2상
The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease [uMRD < or 10^-4 in peripheral blood (PB)] by end of combination treatment (EOCT) to allow off-treatment period.
The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
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Arkansas
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Springdale, Arkansas, 미국, 72762
- Highlands Oncology Group
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Colorado
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Aurora, Colorado, 미국, 80012-5405
- Rocky Mountain Cancer Centers (Aurora) - USOR
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Florida
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Jacksonville, Florida, 미국, 32256-6932
- Cancer Specialists of North Florida
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Indiana
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Fort Wayne, Indiana, 미국, 46804
- Fort Wayne Medical Oncology and Hematology, Inc
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Iowa
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Des Moines, Iowa, 미국, 50314-3030
- Mission Blood and Cancer - MercyOne Cancer Center
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Maryland
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Bethesda, Maryland, 미국, 20817-1915
- American Oncology Partners of Maryland, PA
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Massachusetts
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Boston, Massachusetts, 미국, 02215-5418
- Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center
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Nebraska
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Grand Island, Nebraska, 미국, 68803
- Nebraska Cancer Specialists St Francis - Grand Island
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Omaha, Nebraska, 미국, 68130-2042
- Nebraska Cancer Specialists
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New Jersey
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East Brunswick, New Jersey, 미국, 08816-4096
- Astera Cancer Care East Brunswick
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New Mexico
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Farmington, New Mexico, 미국, 87401
- San Juan Oncology Associates, PC
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Ohio
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Cincinnati, Ohio, 미국, 45236-2725
- Oncology Hematology Care Inc - Cincinnati - USOR
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Columbus, Ohio, 미국, 43210
- Ohio State University
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Oregon
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Eugene, Oregon, 미국, 97401-6043
- Willamette Valley Cancer Institute and Research Center
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Medford, Oregon, 미국, 97504-8332
- Asante Rogue Regional Medical Center
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- Tennessee Oncology, PLLC - Chattanooga
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology - Midtown
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Texas
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Houston, Texas, 미국, 77030
- MD Anderson Cancer Center
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Tyler, Texas, 미국, 75702
- Texas Oncology- Northeast Texas
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a response of at least a PR per iwCLL criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 2
- Adequate renal and liver function
Exclusion Criteria:
- Prior B-cell lymphoma (Bcl-2) inhibitor therapy
- Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
- Progressive or stable disease on cBTKi
- Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
- History of cardiomyopathy
- Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
- Clinically significant cardiovascular disease
- Active bleeding or history of bleeding diathesis
- Pregnant women and nursing mothers
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Venetoclax Added to cBTKi (Commercially Prescribed)
Participants will receive venetoclax, orally, once daily (QD) with a starting ramp-up dose of 20 milligrams (mg) on Day 1 of Cycle 1 (cycle length= 28 days). The dose will increase weekly; thereafter, treatment will continue with venetoclax at the target dose of 400 mg, QD from Week 5 up to Day 28 of Cycle 12. Participant will discontinue from venetoclax and/or cBTKi after 12 cycles. Participants with detectable measurable residual disease with the presence of less than 1 CLL cell in 10,000 leukocytes (< 10^-4) (MRD4) or uMRD4 with partial response (PR) may continue receiving cBTKi-monotherapy (i.e. ibrutinib or acalabrutinib, or zanubrutinib) as previously prescribed by the investigator according to the prescribing label. |
Venetoclax tablets will be administered as per the schedule specified in the arm.
다른 이름들:
Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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uMRD4 Rate at EOCT
기간: Cycle 12 Day 28 (Cycle length= 28 Days)
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uMRD4 will be assessed using next generation sequencing (NGS) (sensitivity 10^-4) from PB. |
Cycle 12 Day 28 (Cycle length= 28 Days)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CR/CRi Rate at EOCT as Determined by the Investigator According to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines
기간: Up to approximately 12 months
|
Complete response (CR)/complete response with incomplete recovery of the bone marrow (CRi) rate is defined as the percentage of participants with a CR or CRi at EOCT, as determined by the investigator according to the iwCLL. |
Up to approximately 12 months
|
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PR Rate at EOCT as Determined by the Investigator According to iwCLL Guidelines
기간: Up to approximately 12 months
|
PR rate is defined as the percentage of participants with a PR at EOCT, as determined by the investigator according to the iwCLL. |
Up to approximately 12 months
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Overall Response Rate (ORR) at EOCT as Determined by the Investigator According to iwCLL Guidelines
기간: Up to approximately 12 months
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ORR is defined as the percentage of participants with a CR/CRi or PR at EOCT, as determined by the investigator according to the iwCLL. |
Up to approximately 12 months
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: Up to approximately 13 months
|
AE and SAEs will be collected as part of this study at baseline and every clinical visit, until 30 days after the final dose of study treatment. |
Up to approximately 13 months
|
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Number of Participants Who Withdrew Prematurely from the Study
기간: Up to approximately 12 months
|
Participants who discontinued treatment before Cycle 12 Day 28 (cycle length= 28 days). |
Up to approximately 12 months
|
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Overall Survival (OS)
기간: Up to approximately 48 months
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OS is defined as the time from the first study treatment to death from any cause. |
Up to approximately 48 months
|
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Progression-free Survival (PFS) as Determined by the Investigator According to iwCLL Guidelines
기간: Up to approximately 48 months
|
PFS is defined as the time from the first study treatment to the first occurrence of disease progression (PD) or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL. |
Up to approximately 48 months
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Event-free Survival (EFS) as Determined by the Investigator According to iwCLL Guidelines
기간: Up to approximately 48 months
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EFS is defined as the time from the first study treatment to the first occurrence of PD, anti-leukemic treatment subsequent to the study treatment, or death from any cause during study, whichever occurs first, as determined by the investigator according to the iwCLL. |
Up to approximately 48 months
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Duration of Response (DOR) in Participants With CR/CRi or PR as Determined by the Investigator According to iwCLL Guidelines
기간: Up to approximately 12 months
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DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR/CRi or PR) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL. |
Up to approximately 12 months
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DOR in Participants With CR or CRi as Determined by the Investigator According to iwCLL Guidelines
기간: Up to approximately 12 months
|
DOR is defined as the time from the first occurrence of a documented objective response (i.e., CR or CRi ) to PD or death from any cause, whichever occurs first, as determined by the investigator according to the iwCLL. |
Up to approximately 12 months
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Time to Next CLL Treatment (TTNT)
기간: Up to approximately 12 months
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TTNT is defined as the time from the first study treatment to the start of anti-leukemic treatment subsequent to the study treatment or death, whichever occurs first. |
Up to approximately 12 months
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Clinical Trials, Hoffmann-La Roche
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- ML45219
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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