En studie av JNJ-75276617 hos deltakere med akutt leukemi (cAMeLot-1)
En første i menneskelig studie av Menin-KMT2A (MLL1)-hemmeren JNJ-75276617 hos deltakere med akutt leukemi
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.
Studieoversikt
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Clayton, Australia, 3168
- Rekruttering
- Monash Medical Centre
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Perth, Australia, 6000
- Rekruttering
- Royal Perth Hospital
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Southport, Australia, 4211
- Rekruttering
- Gold Coast University Hospital
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Ghent, Belgia, 9000
- Rekruttering
- Ghent University Hospital
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Brasília, Brasil, 70390-140
- Rekruttering
- IDOR - Regional Brasilia
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Natal, Brasil, 59062 000
- Rekruttering
- Liga Norte Riograndense Contra O Cancer
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Rio de Janeiro, Brasil, 20230 130
- Rekruttering
- Ministerio da Saude Instituto Nacional do Cancer
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São Paulo, Brasil, 01246 000
- Rekruttering
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasil, 01509 900
- Rekruttering
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasil, 01401 002
- Rekruttering
- IDOR - Regional Sao Paulo
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Rekruttering
- Vancouver Coastal Health
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Ontario
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Toronto, Ontario, Canada, M5G 1X6
- Rekruttering
- Princess Margaret Cancer Centre University Health Network
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Rekruttering
- Hopital Maisonneuve Rosemont
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California
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Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope
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Orange, California, Forente stater, 92868
- Fullført
- University of California Irvine Medical Center
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San Francisco, California, Forente stater, 94143
- Rekruttering
- University of California San Francisco
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San Francisco, California, Forente stater, 94158
- Rekruttering
- UCSF Benioff Children's Hospital
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Illinois
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago
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Indiana
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Indianapolis, Indiana, Forente stater, 46237
- Rekruttering
- St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
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Kentucky
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Louisville, Kentucky, Forente stater, 40207
- Fullført
- Norton Cancer Institute
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Maine
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South Portland, Maine, Forente stater, 04106
- Rekruttering
- Maine Health
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Rekruttering
- Massachusetts General Hospital
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Boston, Massachusetts, Forente stater, 02115
- Rekruttering
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, Forente stater, 48201 2013
- Fullført
- Karmanos Cancer Institute
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Grand Rapids, Michigan, Forente stater, 49546
- Rekruttering
- Start Midwest
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87131
- Rekruttering
- University of New Mexico
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New York
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Buffalo, New York, Forente stater, 14263
- Rekruttering
- Roswell Park Comprehensive Cancer Center
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New York, New York, Forente stater, 10016
- Rekruttering
- NYU Langone Medical Center
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The Bronx, New York, Forente stater, 10467
- Rekruttering
- Montefiore Medical Center
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Oregon
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
- Fullført
- Fox Chase Cancer Center
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Tennessee
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Knoxville, Tennessee, Forente stater, 37920
- Rekruttering
- University of Tennessee Medical Center
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Texas
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Dallas, Texas, Forente stater, 75246
- Rekruttering
- Baylor University Medical Center
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Houston, Texas, Forente stater, 77030
- Rekruttering
- MD Anderson
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Houston, Texas, Forente stater, 77030-2740
- Rekruttering
- Houston Methodist Hospital
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San Antonio, Texas, Forente stater, 78229
- Rekruttering
- San Antonio Methodist TX Transplant Physicians Group
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Virginia
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Richmond, Virginia, Forente stater, 23298
- Rekruttering
- Virginia Commonwealth University
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Washington
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Seattle, Washington, Forente stater, 98104
- Rekruttering
- Swedish Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Rekruttering
- Medical College of WI at Froedtert
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Besançon, Frankrike, 25000
- Rekruttering
- Hopital Jean Minjoz
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Marseille, Frankrike, 13009
- Rekruttering
- Institut Paoli Calmettes
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Nantes, Frankrike, 44093
- Rekruttering
- CHU de Nantes hotel Dieu
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Paris, Frankrike, 75010
- Rekruttering
- Hopital Saint Louis
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Paris, Frankrike, 75012
- Rekruttering
- Hopital trousseau- APHP
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Pessac, Frankrike, 33604
- Fullført
- Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
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Pierre-Bénite, Frankrike, 69310
- Rekruttering
- CHU Lyon Sud
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Strasbourg, Frankrike, 67098
- Rekruttering
- Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
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Toulouse, Frankrike, 31059
- Rekruttering
- Institut Universitaire du Cancer Toulouse Oncopole
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Tours, Frankrike, 37044
- Rekruttering
- CHU Bretonneau
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Vandœuvre-lès-Nancy, Frankrike, 54511
- Rekruttering
- CHRU Nancy Brabois
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Vandœuvre-lès-Nancy, Frankrike, 54500
- Rekruttering
- CHRU de Nancy - Hopitaux de Brabois
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Villejuif, Frankrike, 94805
- Rekruttering
- Gustave Roussy
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Haifa, Israel, 3436212
- Rekruttering
- Carmel Medical Center
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Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah University Hospita Ein Kerem
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Ramat Gan, Israel, 52621
- Rekruttering
- Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Rekruttering
- Tel Aviv Sourasky Medical Center
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Fukuoka, Japan, 812-0054
- Aktiv, ikke rekrutterende
- Kyushu University Hospital
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Fukushima, Japan, 960 1295
- Aktiv, ikke rekrutterende
- Fukushima Medical University Hospital
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Kanazawa, Japan, 920 8641
- Aktiv, ikke rekrutterende
- Kanazawa University Hospital
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Kashiwa, Japan, 277-8577
- Aktiv, ikke rekrutterende
- National Cancer Center Hospital East
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Kobe, Japan, 650 0047
- Fullført
- Kobe City Medical Center General Hospital
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Maebashi, Japan, 371-0821
- Fullført
- Gunmaken Saiseikai Maebashi Hospital
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Nagoya, Japan, 466-8560
- Fullført
- Nagoya University Hospital
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Sapporo, Japan, 060-8648
- Fullført
- Hokkaido University Hospital
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Tokyo, Japan, 141-8625
- Aktiv, ikke rekrutterende
- NTT Medical Center Tokyo
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Yamagata, Japan, 990 2331
- Fullført
- Yamagata University Hospital
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Yoshida, Japan, 910-1193
- Fullført
- University of Fukui Hospital
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Beijing, Kina, 100034
- Rekruttering
- Peking University First Hospital
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Changchun, Kina, 130021
- Rekruttering
- The First Hospital of Jilin University
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Chengdu, Kina, 610041
- Rekruttering
- West China Hospital Si Chuan University
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Guangzhou, Kina, 510515
- Fullført
- Nanfang Hospital of Southern Medical Hospital
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Hangzhou, Kina, 310009
- Rekruttering
- First Affiliated Hospital Medical School of Zhejiang University
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Jinan, Kina, 250012
- Rekruttering
- Qilu Hospital of Shandong University
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Nanchang, Kina, 330006
- Rekruttering
- The First Affiliated Hospital of NanChang University
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Nanjing, Kina, 210009
- Rekruttering
- Zhongda Hospital Southeast University
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Tianjin, Kina, 301609
- Rekruttering
- Institute of Hematology and Blood Diseases Hospital
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Wenzhou, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Kina, 430022
- Rekruttering
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Zhengzhou, Kina, 450003
- Rekruttering
- Henan Cancer Hospital
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Barcelona, Spania, 08036
- Rekruttering
- Hosp Clinic de Barcelona
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Barcelona, Spania, 08035
- Rekruttering
- Hosp Univ Vall D Hebron
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Madrid, Spania, 28009
- Rekruttering
- Hospital Infantil Universitario Nino Jesus
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Madrid, Spania, 28007
- Rekruttering
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spania, 28040
- Rekruttering
- Hosp Univ Fund Jimenez Diaz
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Pamplona, Spania, 31008
- Rekruttering
- Clinica Univ. de Navarra
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Salamanca, Spania, 37007
- Rekruttering
- Hosp Clinico Univ de Salamanca
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Seville, Spania, 41013
- Rekruttering
- Hosp. Virgen Del Rocio
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Valencia, Spania, 46010
- Rekruttering
- Hosp. Clinico Univ. de Valencia
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Cardiff, Storbritannia, CF14 4XW
- Rekruttering
- University Hospital of Wales
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Leeds, Storbritannia, LS9 7TF
- Rekruttering
- Leeds Teaching Hospitals NHS Trust
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Liverpool, Storbritannia, L7 8YA
- Rekruttering
- The Clatterbridge Cancer Centre
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London, Storbritannia, SE1 9RT
- Rekruttering
- Guys and St Thomas NHS Foundation Trust
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London, Storbritannia, W1T 7HA
- Rekruttering
- University College London Hospitals
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Manchester, Storbritannia, M20 4BX
- Rekruttering
- The Christie Nhs Foundation Trust
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Oxfordshire, Storbritannia, OX3 7LE
- Rekruttering
- Oxford University Hospitals NHS Trust
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Plymouth, Storbritannia, PL6 8DH
- Rekruttering
- University Hospitals Plymouth NHS Trust
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital
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Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center
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Taichung, Taiwan, 404327
- Rekruttering
- China Medical University Hospital
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Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10043
- Rekruttering
- National Taiwan University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Up to 28 days Cycle 1
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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
|
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Phase 2: Rate of Complete Remission or Complete Remission with Partial Hematologic Recovery (CR/CRh)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 1 and 2: Plasma Concentration of Bleximenib
Tidsramme: Up to 4 years and 9 months
|
Plasma concentration of bleximenib will be reported. |
Up to 4 years and 9 months
|
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Phase 1 and 2: Overall Response Rate (ORR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CR108998
- 75276617ALE1001 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-506581-31-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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