급성 백혈병 환자의 JNJ-75276617 연구 (cAMeLot-1)
급성 백혈병 환자의 Menin-KMT2A(MLL1) 억제제 JNJ-75276617에 대한 최초의 인간 연구
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Taichung, 대만, 404327
- 모병
- China Medical University Hospital
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Tainan, 대만, 704
- 모병
- National Cheng Kung University Hospital
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Taipei, 대만, 10043
- 모병
- National Taiwan University Hospital
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Seoul, 대한민국, 05505
- 모병
- Asan Medical Center
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Seoul, 대한민국, 03080
- 모병
- Seoul National University Hospital
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Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
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California
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Duarte, California, 미국, 91010
- 모병
- City of Hope
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Orange, California, 미국, 92868
- 완전한
- University of California Irvine Medical Center
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San Francisco, California, 미국, 94143
- 모병
- University of California San Francisco
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San Francisco, California, 미국, 94158
- 모병
- UCSF Benioff Children's Hospital
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Illinois
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Chicago, Illinois, 미국, 60637
- 모병
- University of Chicago
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Indiana
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Indianapolis, Indiana, 미국, 46237
- 모병
- St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
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Kentucky
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Louisville, Kentucky, 미국, 40207
- 완전한
- Norton Cancer Institute
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Maine
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South Portland, Maine, 미국, 04106
- 모병
- Maine Health
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모병
- Massachusetts General Hospital
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Boston, Massachusetts, 미국, 02115
- 모병
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, 미국, 48201 2013
- 완전한
- Karmanos Cancer Institute
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Grand Rapids, Michigan, 미국, 49546
- 모병
- Start Midwest
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New Mexico
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Albuquerque, New Mexico, 미국, 87131
- 모병
- University of New Mexico
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New York
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Buffalo, New York, 미국, 14263
- 모병
- Roswell Park Comprehensive Cancer Center
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New York, New York, 미국, 10016
- 모병
- NYU Langone Medical Center
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The Bronx, New York, 미국, 10467
- 모병
- Montefiore Medical Center
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Oregon
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Portland, Oregon, 미국, 97239
- 모병
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19111
- 완전한
- Fox Chase Cancer Center
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Tennessee
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Knoxville, Tennessee, 미국, 37920
- 모병
- University of Tennessee Medical Center
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Texas
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Dallas, Texas, 미국, 75246
- 모병
- Baylor University Medical Center
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Houston, Texas, 미국, 77030
- 모병
- MD Anderson
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Houston, Texas, 미국, 77030-2740
- 모병
- Houston Methodist Hospital
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San Antonio, Texas, 미국, 78229
- 모병
- San Antonio Methodist TX Transplant Physicians Group
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Virginia
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Richmond, Virginia, 미국, 23298
- 모병
- Virginia Commonwealth University
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Washington
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Seattle, Washington, 미국, 98104
- 모병
- Swedish Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- 모병
- Medical College of WI at Froedtert
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Ghent, 벨기에, 9000
- 모병
- Ghent University Hospital
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Brasília, 브라질, 70390-140
- 모병
- IDOR - Regional Brasilia
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Natal, 브라질, 59062 000
- 모병
- Liga Norte Riograndense Contra O Cancer
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Rio de Janeiro, 브라질, 20230 130
- 모병
- Ministerio da Saude Instituto Nacional do Cancer
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São Paulo, 브라질, 01246 000
- 모병
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, 브라질, 01509 900
- 모병
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, 브라질, 01401 002
- 모병
- IDOR - Regional Sao Paulo
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Barcelona, 스페인, 08036
- 모병
- Hosp Clinic de Barcelona
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Barcelona, 스페인, 08035
- 모병
- Hosp Univ Vall D Hebron
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Madrid, 스페인, 28009
- 모병
- Hospital Infantil Universitario Nino Jesus
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Madrid, 스페인, 28007
- 모병
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, 스페인, 28040
- 모병
- Hosp Univ Fund Jimenez Diaz
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Pamplona, 스페인, 31008
- 모병
- Clinica Univ. de Navarra
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Salamanca, 스페인, 37007
- 모병
- Hosp Clinico Univ de Salamanca
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Seville, 스페인, 41013
- 모병
- Hosp. Virgen Del Rocio
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Valencia, 스페인, 46010
- 모병
- Hosp. Clinico Univ. de Valencia
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Cardiff, 영국, CF14 4XW
- 모병
- University Hospital of Wales
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Leeds, 영국, LS9 7TF
- 모병
- Leeds Teaching Hospitals NHS Trust
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Liverpool, 영국, L7 8YA
- 모병
- The Clatterbridge Cancer Centre
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London, 영국, SE1 9RT
- 모병
- Guys and St Thomas NHS Foundation Trust
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London, 영국, W1T 7HA
- 모병
- University College London Hospitals
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Manchester, 영국, M20 4BX
- 모병
- The Christie Nhs Foundation Trust
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Oxfordshire, 영국, OX3 7LE
- 모병
- Oxford University Hospitals NHS Trust
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Plymouth, 영국, PL6 8DH
- 모병
- University Hospitals Plymouth NHS Trust
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Haifa, 이스라엘, 3436212
- 모병
- Carmel Medical Center
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Jerusalem, 이스라엘, 9112001
- 모병
- Hadassah University Hospita Ein Kerem
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Ramat Gan, 이스라엘, 52621
- 모병
- Sheba Medical Center
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Tel Aviv, 이스라엘, 6423906
- 모병
- Tel Aviv Sourasky Medical Center
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Fukuoka, 일본, 812-0054
- 모집하지 않고 적극적으로
- Kyushu University Hospital
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Fukushima, 일본, 960 1295
- 모집하지 않고 적극적으로
- Fukushima Medical University Hospital
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Kanazawa, 일본, 920 8641
- 모집하지 않고 적극적으로
- Kanazawa University Hospital
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Kashiwa, 일본, 277-8577
- 모집하지 않고 적극적으로
- National Cancer Center Hospital East
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Kobe, 일본, 650 0047
- 완전한
- Kobe City Medical Center General Hospital
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Maebashi, 일본, 371-0821
- 완전한
- Gunmaken Saiseikai Maebashi Hospital
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Nagoya, 일본, 466-8560
- 완전한
- Nagoya University Hospital
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Sapporo, 일본, 060-8648
- 완전한
- Hokkaido University Hospital
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Tokyo, 일본, 141-8625
- 모집하지 않고 적극적으로
- NTT Medical Center Tokyo
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Yamagata, 일본, 990 2331
- 완전한
- Yamagata University Hospital
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Yoshida, 일본, 910-1193
- 완전한
- University of Fukui Hospital
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Beijing, 중국, 100034
- 모병
- Peking University First Hospital
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Changchun, 중국, 130021
- 모병
- The First Hospital of Jilin University
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Chengdu, 중국, 610041
- 모병
- West China Hospital Si Chuan University
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Guangzhou, 중국, 510515
- 완전한
- Nanfang Hospital of Southern Medical Hospital
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Hangzhou, 중국, 310009
- 모병
- First Affiliated Hospital Medical School of Zhejiang University
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Jinan, 중국, 250012
- 모병
- Qilu Hospital of Shandong University
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Nanchang, 중국, 330006
- 모병
- The First Affiliated Hospital of NanChang University
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Nanjing, 중국, 210009
- 모병
- Zhongda Hospital Southeast University
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Tianjin, 중국, 301609
- 모병
- Institute of Hematology and Blood Diseases Hospital
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Wenzhou, 중국, 325000
- 모병
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, 중국, 430022
- 모병
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Zhengzhou, 중국, 450003
- 모병
- Henan Cancer Hospital
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- 모병
- Vancouver Coastal Health
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Ontario
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Toronto, Ontario, 캐나다, M5G 1X6
- 모병
- Princess Margaret Cancer Centre University Health Network
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Quebec
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Montreal, Quebec, 캐나다, H1T 2M4
- 모병
- Hopital Maisonneuve Rosemont
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Besançon, 프랑스, 25000
- 모병
- Hopital Jean Minjoz
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Marseille, 프랑스, 13009
- 모병
- Institut Paoli Calmettes
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Nantes, 프랑스, 44093
- 모병
- CHU de Nantes hotel Dieu
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Paris, 프랑스, 75010
- 모병
- Hopital Saint Louis
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Paris, 프랑스, 75012
- 모병
- Hopital trousseau- APHP
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Pessac, 프랑스, 33604
- 완전한
- Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
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Pierre-Bénite, 프랑스, 69310
- 모병
- CHU Lyon Sud
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Strasbourg, 프랑스, 67098
- 모병
- Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
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Toulouse, 프랑스, 31059
- 모병
- Institut Universitaire du Cancer Toulouse Oncopole
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Tours, 프랑스, 37044
- 모병
- CHU Bretonneau
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Vandœuvre-lès-Nancy, 프랑스, 54511
- 모병
- CHRU Nancy Brabois
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Vandœuvre-lès-Nancy, 프랑스, 54500
- 모병
- CHRU de Nancy - Hopitaux de Brabois
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Villejuif, 프랑스, 94805
- 모병
- Gustave Roussy
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Clayton, 호주, 3168
- 모병
- Monash Medical Centre
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Perth, 호주, 6000
- 모병
- Royal Perth Hospital
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Southport, 호주, 4211
- 모병
- Gold Coast University Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Phase 1:
- Age 2 years to less than (<) 18 years of age (pediatric cohort only), all other cohorts 18 years and above
- Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
- Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations
Phase: 2
- Participants greater than 18 years are eligible
- Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
- AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only
For Both Phase 1 and 2:
- Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count <= 20*10^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate >= 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate >=40 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric 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
- Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment
Exclusion Criteria:
- Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
- Active central nervous system (CNS) disease
- Prior solid organ transplantation
- QTc according to Fridericia's formula (QTcF) for males >= 450 millisecond (msec) or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
- Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment ; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
- Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Bleximenib
Participants in Phase 1 Part 1 (dose escalation) will receive bleximenib orally. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) have been identified. Participants in Phase 1 Part 2 (dose expansion) will receive bleximenib orally at the RP2D(s) determined in Part 1. In Phase 2 participants will receive bleximenib at the RP2D to evaluate anti-leukemia activity and demonstrate acceptable safety at the RP2D(s). |
Bleximenib is administered orally.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
기간: Up to 4 years and 9 months
|
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 4 years and 9 months
|
|
Phase 1: Number of Participants with AEs by Severity
기간: Up to 4 years and 9 months
|
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 4 years and 9 months
|
|
Phase 1: Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT)
기간: Up to 28 days Cycle 1
|
Percentage of participants with DLT will be assessed accordingly to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5. |
Up to 28 days Cycle 1
|
|
Phase 2: Rate of Complete Remission or Complete Remission with Partial Hematologic Recovery (CR/CRh)
기간: Up to 4 years and 9 months
|
Rate of CR/CRh is defined as the percentage of participants achieving a CR or CRh at any time post-treatment. |
Up to 4 years and 9 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 1 and 2: Plasma Concentration of Bleximenib
기간: Up to 4 years and 9 months
|
Plasma concentration of bleximenib will be reported. |
Up to 4 years and 9 months
|
|
Phase 1 and 2: Overall Response Rate (ORR)
기간: Up to 4 years and 9 months
|
ORR is defined as the percentage of participants who achieve any response. |
Up to 4 years and 9 months
|
|
Phase 1: Duration of Response (DOR)
기간: Up to 4 years and 9 months
|
DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first. |
Up to 4 years and 9 months
|
|
Phase 1 and 2: Time To Response (TTR)
기간: Up to 4 years and 9 months
|
TTR is defined for the responders as the time from the date of the first dose of bleximenib to the date of the first documented response. |
Up to 4 years and 9 months
|
|
Phase 2: Duration of Complete Response (CR)/Complete Remission With Partial Hematologic Recovery (CRh)
기간: Up to 4 years and 9 months
|
The duration of CR/CRh is defined from the date of first CR or CRh response achieved to the date of first evidence of relapsed disease or death due to any cause, whichever occurs first, for participants who achieve a CR or CRh. |
Up to 4 years and 9 months
|
|
Phase 2: Time To CR/CRh
기간: Up to 4 years and 9 months
|
Time to CR/CRh is defined for responders as the time from the date of the first dose of bleximenib to the date of first achieving either CR or CRh, depending on which milestone is reached. |
Up to 4 years and 9 months
|
|
Phase 2: Event-free survival (EFS)
기간: Up to 4 years and 9 months
|
EFS is defined as the time from the date of first dose of study treatment to the date of treatment failure, relapse, or death due to any cause, whichever occurs first. |
Up to 4 years and 9 months
|
|
Phase 2: Overall survival (OS)
기간: Up to 4 years and 9 months
|
OS is defined from the date of first dose of study treatment to the date of death due to any cause. |
Up to 4 years and 9 months
|
|
Phase 2: Measurable Residual Disease (MRD) Negativity Among Participants Achieving CR/CRh/CRi
기간: Up to 4 years and 9 months
|
MRD-negative rate is defined as the percentage of participants who are MRD-negative at any timepoint after the first dose of bleximenib in the responders. |
Up to 4 years and 9 months
|
|
Phase 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: Up to 4 years and 9 months
|
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A Serious AE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Up to 4 years and 9 months
|
|
Phase 2: Number of Participants Reporting Transfusion Independence
기간: Up to 4 years and 9 months
|
Transfusion independence is defined as independence from red blood cells (RBC) and platelet transfusions during any 56-day interval after receiving study treatment. |
Up to 4 years and 9 months
|
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
기타 연구 ID 번호
기타 연구 ID 번호
- CR108998
- 75276617ALE1001 (기타 식별자: Janssen Research & Development, LLC)
- 2023-506581-31-00 (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. .