AzTrials
AzTrials

Leukemia, Myeloid, AcutePhase 3cAMeLot-2NCT06852222

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

A Phase 3 study testing Bleximenib, Venetoclax (VEN) and Azacitidine (AZA) in people with Leukemia, Myeloid, Acute, run by Janssen Research & Development, LLC at 270 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Bleximenib, Venetoclax (VEN) and Azacitidine (AZA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
270 sitesin 26 countries
Study dates
4 Jun 2025to 15 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be 18 years of age or older at the time of informed consent
  • Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
  • Ineligible for intensive chemotherapy based on the following criteria: a) >= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) >=18 to <75 years of age with >= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
  • Participants must have adequate hepatic and renal function
  • A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
  • A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
  • Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Who cannot join

  • Diagnosis of acute promyelocytic leukemia (APL)
  • Known active leukemic involvement of the central nervous system (CNS)
  • Recipient of solid organ transplant
  • Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
  • Active infectious hepatitis
  • Live, attenuated vaccine within 4 weeks of randomization
  • Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients

Trial locations and contacts

270 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

270 sites in 26 countries

United States61 sites, 61 recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

    Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

    Recruiting

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

    Recruiting

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Recruiting

  • Atrium Health

    Charlotte, North Carolina, 28204

    Recruiting

  • Novant Health Charlotte

    Charlotte, North Carolina, 28204

    Recruiting

  • Carolina Oncology Specialists

    Charlotte, North Carolina, 28207

    Recruiting

  • University of Chicago Medicine

    Chicago, Illinois, 60637

    Recruiting

  • Oncology Hematology Care

    Cincinnati, Ohio, 45226

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33901

    Recruiting

  • Cancer Treatment Center of America Phoenix

    Goodyear, Arizona, 85338

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

    Recruiting

  • Jupiter Research

    Jupiter, Florida, 33458

    Recruiting

  • University of Tennessee

    Knoxville, Tennessee, 37920

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Recruiting

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536

    Recruiting

  • University of Arkansas at Little Rock

    Little Rock, Arkansas, 72204

    Recruiting

  • UofL Health Brown Cancer Center

    Louisville, Kentucky, 40202

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

    Recruiting

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • New York Presbyterian - Weill Cornell

    New York, New York, 10065

    Recruiting

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

    Recruiting

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

    Recruiting

  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando

    Orlando, Florida, 32804

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Recruiting

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33026

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15260

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Recruiting

  • Providence Oncology and Hematology Care Clinic Westside

    Portland, Oregon, 97225

    Recruiting

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia, 23298

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Recruiting

  • Intermountain Healthcare LDS Hospital

    Salt Lake City, Utah, 84143

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • MaineHealth Institute for Research

    South Portland, Maine, 04106

    Recruiting

  • Washington University in St Louis

    St Louis, Missouri, 63130

    Recruiting

  • Moffit Cancer center

    Tampa, Florida, 33612

    Recruiting

  • Einstein-Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

    Recruiting

  • Texas Oncology - Northeast

    Tyler, Texas, 75702

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Recruiting

  • Novant Health Winston Salem

    Winston-Salem, North Carolina, 27106

    Recruiting

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

    Recruiting

  • Trinity Health Michigan Heart - Ann Arbor Campus

    Ypsilanti, Michigan, 48106

    Recruiting

Other trials in United States

China25 sites, 25 recruiting

  • Peking University First Hospital

    Beijing, 100020

    Recruiting

  • Peking University People's Hospital

    Beijing, 100044

    Recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Recruiting

  • The first Affiliated Hospital of Jilin University

    Changchun, 130021

    Recruiting

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610032

    Recruiting

  • West China Hospital Si Chuan University

    Chengdu, 610041

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 401147

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

    Recruiting

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003

    Recruiting

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    Hefei, 230001

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, 250012

    Recruiting

  • The Second Hospital & Clinical Medical School Lanzhou University

    Lanzhou, 730030

    Recruiting

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

    Recruiting

  • Zhongda Hospital Southeast University

    Nanjing, 210009

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

    Recruiting

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055

    Recruiting

  • The Second People's Hospital of Shenzhen

    Shenzhen, 518035

    Recruiting

  • First Affiliated Hospital SooChow University

    Suzhou, 215005

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tijian, 300020

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022

    Recruiting

  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

    Wuhan, 430030

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004

    Recruiting

  • The first affiliated hospital of xiamen university

    Xiamen, 361003

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450008

    Recruiting

Other trials in China

Japan17 sites, 17 recruiting

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō City, 113 8677

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812 8582

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

    Recruiting

  • Gifu Municipal Hospital

    Gifu, 500-8513

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, 920-8641

    Recruiting

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

    Recruiting

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

    Recruiting

  • Gunmaken Saiseikai Maebashi Hospital

    Maebashi, 371-0821

    Recruiting

  • Nagoya University Hospital

    Nagoya, 466 8560

    Recruiting

  • Okayama University Hospital

    Okayama, 700 8558

    Recruiting

  • Japanese Red Cross Osaka Hospital

    Osaka, 543 8555

    Recruiting

  • Aiiku Hospital

    Sapporo, 064 0804

    Recruiting

  • Tohoku University Hospital

    Sendai, 980 8574

    Recruiting

  • Nippon Medical School Hospital

    Tokyo, 113 8603

    Recruiting

  • University of Tsukuba Hospital

    Tsukuba, 305-8576

    Recruiting

  • Yamagata University Hospital

    Yamagata, 990 2331

    Recruiting

  • University of Fukui Hospital

    Yoshida, 910-1193

    Recruiting

Other trials in Japan

Spain16 sites, 16 recruiting

  • Hosp Univ A Coruna

    A Coruña, 15006

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041

    Recruiting

  • Hosp. San Pedro de Alcantara

    Cáceres, 10003

    Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

    Recruiting

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08908

    Recruiting

  • Clinica Univ. de Navarra Madrid

    Madrid, 28027

    Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008

    Recruiting

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

    Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

    Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013

    Recruiting

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

Italy14 sites, 14 recruiting

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127

    Recruiting

  • A O U Sant Orsola Malpighi

    Bologna, 40138

    Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

    Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

    Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

    Perugia, 06132

    Recruiting

  • AST Pesaro e Urbino Ospedale San Salvatore

    Pesaro, 61121

    Recruiting

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

    Recruiting

  • Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

    Reggio Calabria, 89124

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013

    Recruiting

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126

    Recruiting

Other trials in Italy

France13 sites, 13 recruiting

  • CHU d'Angers

    Angers, 49933

    Recruiting

  • CHU de Clermont Ferrand - Site Estaing

    Clermont-Ferrand, 63100

    Recruiting

  • Hopital Saint Vincent de Paul

    Lille, 59020

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273

    Recruiting

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295

    Recruiting

  • CHU De Nice Hopital De l'Archet

    Nice, 06202

    Recruiting

  • Hopital Saint Louis

    Paris, 75010

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite, 69310

    Recruiting

  • CHU Reims Hopital Robert Debre

    Reims, 51100

    Recruiting

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000

    Recruiting

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31100

    Recruiting

  • CHRU de Nancy - Hopitaux de Brabois

    Vandœuvre Ies-Nancy, 54500

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Germany11 sites, 11 recruiting

  • Klinikum Augsburg

    Augsburg, 86156

    Recruiting

  • Universitaetsklinikum Koeln

    Cologne, 50937

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

    Recruiting

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60590

    Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Recruiting

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246

    Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

    Recruiting

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

    Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

    Recruiting

  • Klinikum der Universitaet Muenchen

    München, 81377

    Recruiting

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

    Recruiting

Other trials in Germany

Brazil9 sites, 9 recruiting

  • Fundacao Pio XII

    Barretos, 14780 070

    Recruiting

  • IDOR - Regional Brasilia

    Brasília, 70390 700

    Recruiting

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

    Recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

    Recruiting

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20230 130

    Recruiting

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001

    Recruiting

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 010

    Recruiting

  • IDOR - Regional Sao Paulo

    São Paulo, 01401 002

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900

    Recruiting

Other trials in Brazil

United Kingdom9 sites, 9 recruiting

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

    Recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

    Recruiting

  • Colchester Hospital University NHS

    Colchester, CO4 5JL

    Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Recruiting

  • The Clatterbridge Cancer Centre

    Liverpool, L7 8YA

    Recruiting

  • Guys' and St Thomas' NHS Trust

    London, SE1 9RT

    Recruiting

  • Derriford Hospital

    Plymouth, PL6 8DH

    Recruiting

  • Worthing Hospital

    Worthing, BN11 2DH

    Recruiting

Other trials in United Kingdom

Belgium8 sites, 8 recruiting

  • AZ Sint-Jan

    Bruges, 8000

    Recruiting

  • UZ Antwerpen

    Edegem, 2650

    Recruiting

  • Ziekenhuis Oost-Limburg

    Genk, 3600

    Recruiting

  • Ghent University Hospital

    Ghent, 9000

    Recruiting

  • Chu Helora Hospital La Louviere Site Jolimont

    La Louvière, 7100

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • Clinique Saint Pierre

    Ottignies, 1340

    Recruiting

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Canada8 sites, 8 recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Recruiting

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

    Recruiting

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

    Recruiting

  • London Health Sciences Centre Victoria Hospital

    London, Ontario, N6A 5W9

    Recruiting

  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

    Recruiting

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 2M9

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1N1

    Recruiting

  • Cancercare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Recruiting

Other trials in Canada

Israel8 sites, 8 recruiting

  • Shamir Medical Center Assaf Harofeh

    Beer Yaakov, 7033001

    Recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Carmel Medical Center

    Haifa, 3436212

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Recruiting

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 9112001

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Turkey (Türkiye)8 sites, 8 recruiting

  • Ankara Etlik Sehir Hastanesi

    Ankara, 06170

    Recruiting

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Ankara University School of Medicine Cebeci Hospital

    Ankara, 06590

    Recruiting

  • Memorial Antalya Hospital

    Antalya, 07025

    Recruiting

  • Koc University Medical Faculty

    Istanbul, 34010

    Recruiting

  • VM Medical Park Mersin Hospital

    Mersin, 33200

    Recruiting

  • Sakarya University Training and Research Hospital

    Sakarya, 54100

    Recruiting

  • Ondokuz Mayis University

    Samsun, 55139

    Recruiting

Other trials in Turkey (Türkiye)

Czechia7 sites, 7 recruiting

  • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

    Brno, 625 00

    Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52

    Recruiting

  • Fakultni nemocnice Plzen

    Pilsen, 304 60

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 00

    Recruiting

  • Ustav Hematologie A Krevni Transfuze

    Prague, 128 00

    Recruiting

  • Vseobecna Fakultní Nemocnice

    Prague, 128 08

    Recruiting

Other trials in Czechia

Greece7 sites, 7 recruiting

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

    Recruiting

  • Evaggelismos Hospital

    Athens, 106 76

    Recruiting

  • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

    Chaïdári, 124 62

    Recruiting

  • University General Hospital of Ioannina

    Ioannina, 455 00Q

    Recruiting

  • General University Hospital of Patras

    Rio, 265 04

    Recruiting

  • Ahepa University General Hospital of Thessaloniki

    Thessaloniki, 54636

    Recruiting

  • Geniko Nosokomeio Thessalonikis George Papanikolaou

    Thessaloniki, 570 10

    Recruiting

Other trials in Greece

South Korea7 sites, 7 recruiting

  • Chungnam National University Hospital

    Daejeon, 35015

    Recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 137 701

    Recruiting

Other trials in South Korea

Australia6 sites, 6 recruiting

  • Flinders Medical Centre

    Bedford Park, 5042

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, 2050

    Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

    Recruiting

  • St George Hospital

    Kogarah, 2217

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Recruiting

Other trials in Australia

Austria6 sites, 6 recruiting

  • Kepler Universitatsklinikum GmbH

    Linz, 4020

    Recruiting

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

    Recruiting

  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, 5020

    Recruiting

  • Medical University of Vienna Universitatsklinik fur Innere Medizin I

    Vienna, 1090

    Recruiting

  • Wiener Gesundheitsverbund Klinik Hietzing

    Vienna, 1130

    Recruiting

  • Klinikum Wels Grieskirchen

    Wels, 4600

    Recruiting

Other trials in Austria

Hungary6 sites, 6 recruiting

  • Semmelweis Egyetem

    Budapest, 1088

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About this study

Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Being tested
Bleximenib, Venetoclax (VEN), Azacitidine (AZA), Placebo
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BleximenibDrug

    Also called JNJ-75276617

    Bleximenib will be administered orally.

  • Venetoclax (VEN)Drug

    VEN will be administered orally.

  • Azacitidine (AZA)Drug

    AZA will be administered intravenously or subcutaneously.

  • PlaceboDrug

    Placebo will be administered orally.

Study groups in NCT06852222
Study groupRoleWhat they receive
Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)ExperimentalParticipants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycles and treatment will continue until progression or unacceptable toxicity.
Receives: Drug: Bleximenib; Drug: Venetoclax (VEN); Drug: Azacitidine (AZA)
Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)Placebo comparatorParticipants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycles, and treatment will continue until progression or unacceptable toxicity.
Receives: Drug: Venetoclax (VEN); Drug: Azacitidine (AZA); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants who Achieve Complete Remission (CR)

    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 (1,000/microliter [mcL]); Platelet count >= 100 * 10^9/L (100,000/mcL).

    Measured: Up to 4 years and 1 month

  2. Overall Survival (OS)

    Overall survival time is defined as the time duration from the date of randomization to death due to any cause.

    Measured: Up to 4 years and 1 month

Secondary outcomes (9)

  1. Event-free survival (EFS)

    EFS is defined as the time from randomization to treatment failure, relapse, or death due to any cause, whichever occurs first.

    Measured: Up to 4 years and 1 month

  2. Duration of CR

    Duration of CR will be estimated among responders from the date of initial documentation of CR, to the date of first documented evidence of relapse, or death due to any cause, whichever occurs first, respectively.

    Measured: Up to 4 years and 1 month

  3. Time to CR

    Time to CR is defined as time from randomization to first documented response.

    Measured: Up to 4 years and 1 month

  4. Rate of CR Without Measurable Residual Disease (MRD-)

    Rate of CR MRD- is defined as percentage of participants who have achieved CR without MRD.

    Measured: Up to 4 years and 1 month

  5. Percentage of Participants who Achieved Transfusion Independence

    Transfusion independence is defined as lack of requirement for red blood cell (RBC) and platelet transfusions during any 56-day period.

    Measured: Up to 4 years and 1 month

  6. Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

    Allo-HSCT rate is defined as the percentage of participants who have undergone allo-HSCT after randomization.

    Measured: Up to 4 years and 1 month

  7. Number of Participants with Adverse Events (AEs)

    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. 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.

    Measured: Up to 4 years and 1 month

  8. Number of Participants with Abnormalities in Clinical Laboratory Parameters

    Participants with abnormalities in clinical laboratory parameters will be reported.

    Measured: Up to 4 years and 1 month

  9. Serum Concentration of Bleximenib

    Serum samples will be analyzed to determine concentrations of bleximenib.

    Measured: Up to 4 years and 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start4 Jun 2025
  3. Primary completion22 Jun 2029 (estimated)
  4. Study completion15 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06852222
Sponsor's protocol ID
75276617AML3001
Other IDs
75276617AML3001, 2024-520154-38-00
Acronym
cAMeLot-2
Status last verified
Nov 2026
First submitted
25 Feb 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bleximenib, Venetoclax (VEN) and Azacitidine (AZA) in people with Leukemia, Myeloid, Acute, run by Janssen Research & Development, LLC at 270 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 270 sites in United States, China, Japan, Spain, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve Complete Remission (CR) (time frame: Up to 4 years and 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06852222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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