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Een studie van JNJ-75276617 bij deelnemers met acute leukemie (cAMeLot-1)

2 november 2026 bijgewerkt door: Janssen Research & Development, LLC

Een eerste in humane studie van de Menin-KMT2A (MLL1)-remmer JNJ-75276617 bij deelnemers met acute leukemie

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

420

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Australië
      • Clayton, Australië, 3168
        • Werving
        • Monash Medical Centre
      • Perth, Australië, 6000
        • Werving
        • Royal Perth Hospital
      • Southport, Australië, 4211
        • Werving
        • Gold Coast University Hospital
  • België
      • Ghent, België, 9000
        • Werving
        • Ghent University Hospital
  • Brazilië
      • Brasília, Brazilië, 70390-140
        • Werving
        • IDOR - Regional Brasilia
      • Natal, Brazilië, 59062 000
        • Werving
        • Liga Norte Riograndense Contra O Cancer
      • Rio de Janeiro, Brazilië, 20230 130
        • Werving
        • Ministerio da Saude Instituto Nacional do Cancer
      • São Paulo, Brazilië, 01246 000
        • Werving
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • São Paulo, Brazilië, 01509 900
        • Werving
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo, Brazilië, 01401 002
        • Werving
        • IDOR - Regional Sao Paulo
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Werving
        • Vancouver Coastal Health
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Werving
        • Princess Margaret Cancer Centre University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Werving
        • Hopital Maisonneuve Rosemont
  • China
      • Beijing, China, 100034
        • Werving
        • Peking University First Hospital
      • Changchun, China, 130021
        • Werving
        • The First Hospital of Jilin University
      • Chengdu, China, 610041
        • Werving
        • West China Hospital Si Chuan University
      • Guangzhou, China, 510515
        • Voltooid
        • Nanfang Hospital of Southern Medical Hospital
      • Hangzhou, China, 310009
        • Werving
        • First Affiliated Hospital Medical School of Zhejiang University
      • Jinan, China, 250012
        • Werving
        • Qilu Hospital of Shandong University
      • Nanchang, China, 330006
        • Werving
        • The First Affiliated Hospital of NanChang University
      • Nanjing, China, 210009
        • Werving
        • Zhongda Hospital Southeast University
      • Tianjin, China, 301609
        • Werving
        • Institute of Hematology and Blood Diseases Hospital
      • Wenzhou, China, 325000
        • Werving
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China, 430022
        • Werving
        • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
      • Zhengzhou, China, 450003
        • Werving
        • Henan Cancer Hospital
  • Frankrijk
      • Besançon, Frankrijk, 25000
        • Werving
        • Hopital Jean Minjoz
      • Marseille, Frankrijk, 13009
        • Werving
        • Institut Paoli Calmettes
      • Nantes, Frankrijk, 44093
        • Werving
        • CHU de Nantes hotel Dieu
      • Paris, Frankrijk, 75010
        • Werving
        • Hopital Saint Louis
      • Paris, Frankrijk, 75012
        • Werving
        • Hopital trousseau- APHP
      • Pessac, Frankrijk, 33604
        • Voltooid
        • Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
      • Pierre-Bénite, Frankrijk, 69310
        • Werving
        • CHU Lyon Sud
      • Strasbourg, Frankrijk, 67098
        • Werving
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
      • Toulouse, Frankrijk, 31059
        • Werving
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Tours, Frankrijk, 37044
        • Werving
        • CHU Bretonneau
      • Vandœuvre-lès-Nancy, Frankrijk, 54511
        • Werving
        • CHRU Nancy Brabois
      • Vandœuvre-lès-Nancy, Frankrijk, 54500
        • Werving
        • CHRU de Nancy - Hopitaux de Brabois
      • Villejuif, Frankrijk, 94805
        • Werving
        • Gustave Roussy
  • Israël
      • Haifa, Israël, 3436212
        • Werving
        • Carmel Medical Center
      • Jerusalem, Israël, 9112001
        • Werving
        • Hadassah University Hospita Ein Kerem
      • Ramat Gan, Israël, 52621
        • Werving
        • Sheba Medical Center
      • Tel Aviv, Israël, 6423906
        • Werving
        • Tel Aviv Sourasky Medical Center
  • Japan
      • Fukuoka, Japan, 812-0054
        • Actief, niet wervend
        • Kyushu University Hospital
      • Fukushima, Japan, 960 1295
        • Actief, niet wervend
        • Fukushima Medical University Hospital
      • Kanazawa, Japan, 920 8641
        • Actief, niet wervend
        • Kanazawa University Hospital
      • Kashiwa, Japan, 277-8577
        • Actief, niet wervend
        • National Cancer Center Hospital East
      • Kobe, Japan, 650 0047
        • Voltooid
        • Kobe City Medical Center General Hospital
      • Maebashi, Japan, 371-0821
        • Voltooid
        • Gunmaken Saiseikai Maebashi Hospital
      • Nagoya, Japan, 466-8560
        • Voltooid
        • Nagoya University Hospital
      • Sapporo, Japan, 060-8648
        • Voltooid
        • Hokkaido University Hospital
      • Tokyo, Japan, 141-8625
        • Actief, niet wervend
        • NTT Medical Center Tokyo
      • Yamagata, Japan, 990 2331
        • Voltooid
        • Yamagata University Hospital
      • Yoshida, Japan, 910-1193
        • Voltooid
        • University of Fukui Hospital
  • Spanje
      • Barcelona, Spanje, 08036
        • Werving
        • Hosp Clinic de Barcelona
      • Barcelona, Spanje, 08035
        • Werving
        • Hosp Univ Vall D Hebron
      • Madrid, Spanje, 28009
        • Werving
        • Hospital Infantil Universitario Nino Jesus
      • Madrid, Spanje, 28007
        • Werving
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spanje, 28040
        • Werving
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona, Spanje, 31008
        • Werving
        • Clinica Univ. de Navarra
      • Salamanca, Spanje, 37007
        • Werving
        • Hosp Clinico Univ de Salamanca
      • Seville, Spanje, 41013
        • Werving
        • Hosp. Virgen Del Rocio
      • Valencia, Spanje, 46010
        • Werving
        • Hosp. Clinico Univ. de Valencia
  • Taiwan
      • Taichung, Taiwan, 404327
        • Werving
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • Werving
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10043
        • Werving
        • National Taiwan University Hospital
  • Verenigd Koninkrijk
      • Cardiff, Verenigd Koninkrijk, CF14 4XW
        • Werving
        • University Hospital of Wales
      • Leeds, Verenigd Koninkrijk, LS9 7TF
        • Werving
        • Leeds Teaching Hospitals NHS Trust
      • Liverpool, Verenigd Koninkrijk, L7 8YA
        • Werving
        • The Clatterbridge Cancer Centre
      • London, Verenigd Koninkrijk, SE1 9RT
        • Werving
        • Guys and St Thomas NHS Foundation Trust
      • London, Verenigd Koninkrijk, W1T 7HA
        • Werving
        • University College London Hospitals
      • Manchester, Verenigd Koninkrijk, M20 4BX
        • Werving
        • The Christie Nhs Foundation Trust
      • Oxfordshire, Verenigd Koninkrijk, OX3 7LE
        • Werving
        • Oxford University Hospitals NHS Trust
      • Plymouth, Verenigd Koninkrijk, PL6 8DH
        • Werving
        • University Hospitals Plymouth NHS Trust
  • Verenigde Staten
    • California
      • Duarte, California, Verenigde Staten, 91010
        • Werving
        • City of Hope
      • Orange, California, Verenigde Staten, 92868
        • Voltooid
        • University of California Irvine Medical Center
      • San Francisco, California, Verenigde Staten, 94143
        • Werving
        • University of California San Francisco
      • San Francisco, California, Verenigde Staten, 94158
        • Werving
        • UCSF Benioff Children's Hospital
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • Werving
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46237
        • Werving
        • St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten, 40207
        • Voltooid
        • Norton Cancer Institute
    • Maine
      • South Portland, Maine, Verenigde Staten, 04106
        • Werving
        • Maine Health
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Werving
        • Massachusetts General Hospital
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Werving
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48201 2013
        • Voltooid
        • Karmanos Cancer Institute
      • Grand Rapids, Michigan, Verenigde Staten, 49546
        • Werving
        • Start Midwest
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87131
        • Werving
        • University of New Mexico
    • New York
      • Buffalo, New York, Verenigde Staten, 14263
        • Werving
        • Roswell Park Comprehensive Cancer Center
      • New York, New York, Verenigde Staten, 10016
        • Werving
        • NYU Langone Medical Center
      • The Bronx, New York, Verenigde Staten, 10467
        • Werving
        • Montefiore Medical Center
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Werving
        • Oregon Health And Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19111
        • Voltooid
        • Fox Chase Cancer Center
    • Tennessee
      • Knoxville, Tennessee, Verenigde Staten, 37920
        • Werving
        • University of Tennessee Medical Center
    • Texas
      • Dallas, Texas, Verenigde Staten, 75246
        • Werving
        • Baylor University Medical Center
      • Houston, Texas, Verenigde Staten, 77030
        • Werving
        • MD Anderson
      • Houston, Texas, Verenigde Staten, 77030-2740
        • Werving
        • Houston Methodist Hospital
      • San Antonio, Texas, Verenigde Staten, 78229
        • Werving
        • San Antonio Methodist TX Transplant Physicians Group
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23298
        • Werving
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Werving
        • Swedish Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Werving
        • Medical College of WI at Froedtert
  • Zuid -Korea
      • Seoul, Zuid -Korea, 05505
        • Werving
        • Asan Medical Center
      • Seoul, Zuid -Korea, 03080
        • Werving
        • Seoul National University Hospital
      • Seoul, Zuid -Korea, 06351
        • Werving
        • Samsung Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Geneesmiddel: Bleximenib

Bleximenib is administered orally.

Andere namen:
  • JNJ-75276617

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1 and 2: Plasma Concentration of Bleximenib
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 mei 2021

Primaire voltooiing (Geschat)

29 december 2028

Studie voltooiing (Geschat)

22 september 2030

Studieregistratiedata

Eerst ingediend

22 maart 2021

Eerst ingediend dat voldeed aan de QC-criteria

22 maart 2021

Eerst geplaatst (Werkelijk)

23 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • CR108998
  • 75276617ALE1001 (Andere identificatie: Janssen Research & Development, LLC)
  • 2023-506581-31-00 (Register-ID: EUCT number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren