급성 골수성 백혈병(AML) 지시 요법과 병용한 JNJ-75276617 연구
KMT2A 또는 NPM1 변형이 있는 급성 골수성 백혈병 참가자를 위한 AML 지시 요법과 병용한 JNJ-75276617의 1b상 연구
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
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Berlin, 독일, 13353
- Charite Universitaetsmedizin Berlin
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Dresden, 독일, 01307
- Universitatsklinikum Carl Gustav Carus Dresden
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Heidelberg, 독일, 69120
- Universitaetsklinikum Heidelberg
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Leipzig, 독일, 04103
- Universitaetsklinikum Leipzig
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Ulm, 독일, 89081
- Universitatsklinikum Ulm
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Alabama
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Birmingham, Alabama, 미국, 35233
- The University of Alabama at Birmingham
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California
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Duarte, California, 미국, 91010
- City of Hope
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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New York
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New York, New York, 미국, 10461
- Albert Einstein College Of Medicine
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Novant Health
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Winston-Salem, North Carolina, 미국, 27103
- Novant Health Forsyth Medical Center
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Texas
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Houston, Texas, 미국, 77030
- MD Anderson
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Barcelona, 스페인, 08041
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, 스페인, 08036
- Hosp Clinic de Barcelona
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Barcelona, 스페인, 8035
- Hosp Univ Vall D Hebron
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Madrid, 스페인, 28040
- Hosp Univ Fund Jimenez Diaz
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Pamplona, 스페인, 31008
- Clinica Univ. de Navarra
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London, 영국, NW1 2PG
- University College London Hospitals NHSFT
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Manchester, 영국, M20 4BX
- Christie Hospital NHS Trust
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Oxfordshire, 영국, OX3 7LE
- Oxford University Hospitals NHS Trust
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Bologna, 이탈리아, 40138
- Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
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Meldola, 이탈리아, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, 이탈리아, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Rozzano, 이탈리아, 20089
- IRCCS Istituto Clinico Humanitas
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Ontario
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Toronto, Ontario, 캐나다, M5G 1Z5
- Princess Margaret Cancer Centre University Health Network
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Marseille, 프랑스, 13273
- Institut Paoli Calmettes
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Rennes, 프랑스, 35033
- Chu Rennes Hopital Pontchaillou
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Toulouse, 프랑스, 31100
- Institut Universitaire du Cancer Toulouse Oncopole
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Tours, 프랑스, 37044
- CHU de Tours - Hôpital de Bretonneau
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Clayton, 호주, 3168
- Monash Medical Centre
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Melbourne, 호주, 3000
- Peter MacCallum Cancer Centre
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Westmead, 호주, 2145
- Westmead Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adolescent participants (defined as greater than or equal to [>=] 12 and less than [<] 18 years of age) are only eligible for the relapsed/refractory (R/R) cohort (Arm A, cohort A4)
- Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed/refractory (Arm A only); c) harboring KMT2A, NPM1, NUP98, or NUP214 alterations; d) Participants may receive emergency leukapheresis and/or cytarabine as cytoreductive therapy according to local practice guidelines
- Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to (<=) 25*10^9 per liter (/L), adequate liver and renal function
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Adolescent participants only: Performance status >70 by Lansky scale (for participants <16 years of age) or >70 Karnofsky scale (for participants >16 years of age)
- A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
- Must sign an informed consent form (ICF) indicating participant (or their legally authorized representative) understands the purpose of the study and procedures required for the study and is willing to participate in the study
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Exclusion Criteria:
- Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to WHO 2016 criteria
- Leukemic involvement of the central nervous system
- Recipient of solid organ transplant
- Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to: (a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (<50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment ;(g) Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)
- Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less
- Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation
- Participants with diagnosis of Fanconi anemia, Kostmann syndrome, Shwachman diamond syndrome, or any other known bone marrow failure syndrome
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Arm A: Relapsed/Refractory Setting
Participants with relapsed/refractory AML harboring NPM1, KMT2A, NUP98, or NUP214 alterations will receive bleximenib in combination with either venetoclax (VEN) (Cohort A1: bleximenib+VEN) or azacitidine (AZA) (Cohort A2: bleximenib +AZA) or VEN+AZA (Cohort A3: bleximenib+VEN+AZA) or VEN + AZA (Cohort A4: bleximenib + VEN + AZA) in adolescent participants aged greater than or equal to (>=) 12 years and less than (<) 18 years of age, to select the recommended phase 2 dose (RP2D) of bleximenib in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive bleximenib in combination with AML directed therapies at the RP2D(s). |
Participants will receive bleximenib.
다른 이름들:
Participants will receive VEN. Participants will receive AZA. |
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실험적: Arm B: Newly Diagnosed Chemotherapy Ineligible Setting
Participants will receive bleximenib in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring KMT2A, NPM1, NUP98, or NUP214 alterations who are >=75 years of age or >=18 years of age to <75 years of age with comorbidities that preclude the use of intensive induction chemotherapy. |
Participants will receive bleximenib.
다른 이름들:
Participants will receive VEN. Participants will receive AZA. |
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실험적: Arm C: Newly Diagnosed Chemotherapy Eligible Setting
Participants will receive combination of bleximenib with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants >= 18 to <75 years of age with AML harboring NPM1, KMT2A, NUP98, or NUP214 alterations and eligible for intensive chemotherapy. |
Participants will receive bleximenib.
다른 이름들:
Participants will receive cytarabine. Participants will receive daunorubicin or idarubicin. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants with Adverse Events (AEs)
기간: Up to 3 Years 3 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 3 Years 3 months
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Number of Participants with Adverse Events (AEs) by Severity
기간: Up to 3 Years 3 months
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Number of Participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 3 Years 3 months
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Number of Participants with Dose-limiting Toxicity (DLT)
기간: End of Cycle 1 (28 days)
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Number of participants with DLT will be reported according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. |
End of Cycle 1 (28 days)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Plasma Concentration of Bleximenib
기간: Up to 3 Years 3 months
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Plasma samples will be analyzed to determine concentrations of bleximenib using a validated, specific, and sensitive method. |
Up to 3 Years 3 months
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Number of Participants with Depletion of Leukemic Blasts
기간: Up to 3 Years 3 months
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Number of participants with depletion of leukemic blasts will be reported. |
Up to 3 Years 3 months
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Percentage of Participants who Achieve Complete Remission (CR)
기간: Up to 3 Years 3 months
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Percentage of participants who achieve complete Remission (CR) will be reported. CR is defined as Bone marrow blasts less than (<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (>=) 1.0*10^9/Liter (L) (1,000/microliter [mcL]); Platelet count >= 100 * 10^9/L (100,000/mcL). |
Up to 3 Years 3 months
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Percentage of Participants who Achieve Complete Remission with Partial Hematologic Recovery (CRh)
기간: Up to 3 Years 3 months
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Percentage of participants who achieve complete remission with partial hematologic recovery (CRh) will be reported. CRh is defined as All criteria of CR with both ANC >0.5 * 10^9/L (500/mcL) and platelet count >50 * 10^9/L (50,000/mcL). |
Up to 3 Years 3 months
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Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi)
기간: Up to 3 Years 3 months
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Percentage of participants who achieve complete remission with incomplete hematologic recovery (CRi) will be reported. CRi is defined as All CR criteria except for residual neutropenia (<1.0*10^9/L [1,000/mcL]) or thrombocytopenia (<100 * 10^9/L [100,000/mcL]). |
Up to 3 Years 3 months
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Percentage of Participants who Achieved Overall Response
기간: Up to 3 Years 3 months
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Percentage of participants who achieve overall response will be reported. Overall response rate (ORR) is defined as the percentage of participants achieving CR, CRh, or CRi, morphologic leukemia-free state (MLFS) or partial remission (PR). |
Up to 3 Years 3 months
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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
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
- 신생물
- 조직학적 유형에 따른 신생물
- 혈액 질환
- 백혈병, 골수성
- 백혈병
- 헴 및 림프병
- 백혈병, 골수성, 급성
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 핵산, 뉴클레오티드 및 뉴 클레오 시드
- 탄화수소
- 탄화수소, 순환
- 탄수화물
- 다 환식 방향족 탄화수소
- 탄화수소, 방향족
- 다 환식 화합물
- 글리코 사이드
- 시티 딘
- 피리 미딘 뉴 클레오 시드
- 피리 미딘
- 아자 화합물
- 뉴 클레오 시드
- 리보 뉴 클레오 시드
- 아라비노 뉴 클레오 시드
- 안트라 사이클린
- 나프 타센
- 아미노 글리코 시드
- 시타라빈
- 아자시티딘
- 다우노루비신
- 이다루비신
- Venetoclax
기타 연구 ID 번호
기타 연구 ID 번호
- CR109124
- 2021-003999-14 (EudraCT 번호)
- 75276617ALE1002 (기타 식별자: Janssen Research & Development, LLC)
- 2023-506582-58-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .