Preclinical efficacy of the potent, selective menin-KMT2A inhibitor JNJ-75276617 (bleximenib) in KMT2A- and NPM1-altered leukemias.
Min Chul Kwon, Jan Willem Thuring, Olivier Querolle...
https://pubmed.ncbi.nlm.nih.gov/38905635Actively Recruiting
Phase 1
Phase 2
Age: 2Years +
All Genders
ID04811560
A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Led by Janssen Research & Development, LLC · Updated on 2026-06-08
420
Participants Needed
102
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying bleximenib, a drug given orally, to find the best dose and assess its safety and effectiveness in treating acute leukemia. The study is divided into Phase 1, which focuses on dose finding and safety, and Phase 2, which evaluates how well the drug works at the recommended dose. Participants include children from age 2 and adults with specific genetic changes in their leukemia. In Phase 1 Part 1, participants receive increasing doses of bleximenib to determine the recommended Phase 2 dose based on safety and side effects. Phase 1 Part 2 expands the study at this dose to further assess safety. In Phase 2, participants receive bleximenib at the recommended dose to evaluate its activity against leukemia and its safety profile. During the study, participants will be closely monitored for side effects and treatment response over up to nearly five years. Researchers will measure safety by tracking adverse events and dose-limiting toxicities, and effectiveness by rates of remission and survival. Blood tests will check drug levels and disease markers. Participants must meet specific health criteria and agree to contraception requirements during and after treatment.
CONDITIONS
Brief Title
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Who Can Participate
Age: 2Years +
All Genders
Eligibility Criteria
You may qualify if you...
- For Phase 1 pediatric cohort: age 2 to less than 18 years; for other cohorts: 18 years and older
- Relapsed or refractory acute leukemia with specific gene alterations: KMT2A, NPM1, NUP98, or NUP214
- For Phase 2: adults over 18 with relapsed/refractory acute myeloid leukemia (AML) with KMT2A-r or NPM1 mutations
- Adequate kidney function: adults with glomerular filtration rate (GFR) of at least 30 mL/min; children with GFR of at least 40 mL/min
- White blood cell count less than or equal to 20 x 10^9/L
- Performance status of 0, 1, or 2 (ECOG); pediatric participants must have Lansky or Karnofsky scale of at least 70
- Negative pregnancy test for females of childbearing potential
- Agreement to contraception requirements during and after treatment
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia, Down syndrome-associated leukemia, or juvenile myelomonocytic leukemia
- Active central nervous system disease
- Prior solid organ transplant
- QTc interval above 450 msec for males or 470 msec for females, or family history of Long QT syndrome
- Recent stem cell transplant within 3 months, graft versus host disease, recent donor lymphocyte infusion within 1 month, or need for immunosuppressant therapy above allowed doses
- Prior cancer immunotherapy within 4 weeks or blinatumomab within 2 weeks prior to enrollment
- Other cancer therapies within 4 weeks or 5 half-lives of the agent before enrollment
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 4 years and 9 months
Participants receive Bleximenib orally as part of dose escalation and expansion phases to evaluate safety, tolerability, and anti-leukemia activity.
Regular visits for dosing and monitoring as per protocol
Trial Site Locations
Total: 102 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Irvine Medical Center
Orange, California, United States, 92868
Completed
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158
Actively Recruiting
5
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
6
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
Actively Recruiting
7
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Completed
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201 2013
Completed
11
Start Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
12
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
13
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
14
NYU Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
15
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
16
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
17
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
18
Maine Health
Providence, Rhode Island, United States, 02903
Actively Recruiting
19
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
20
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
21
Houston Methodist Hospital
Houston, Texas, United States, 77030-2740
Actively Recruiting
22
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
23
San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas, United States, 78229
Actively Recruiting
24
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
25
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
26
Medical College of WI at Froedtert
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
27
Monash Medical Centre
Clayton, Australia, 3168
Actively Recruiting
28
Royal Perth Hospital
Perth, Australia, 6000
Actively Recruiting
29
Gold Coast University Hospital
Southport, Australia, 4211
Actively Recruiting
30
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
31
Instituto D Or de Pesquisa e Ensino
Brasília, Brazil, 70390 700
Actively Recruiting
32
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59062 000
Actively Recruiting
33
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, Brazil, 20230 130
Actively Recruiting
34
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil, 01246 000
Actively Recruiting
35
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, Brazil, 01401 002
Actively Recruiting
36
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil, 01509 900
Actively Recruiting
37
Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
38
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada, M5G 1X6
Actively Recruiting
39
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
40
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
41
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
42
West China Hospital Si Chuan University
Chengdu, China, 610041
Actively Recruiting
43
Nanfang Hospital of Southern Medical Hospital
Guangzhou, China, 510515
Actively Recruiting
44
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, China, 310009
Actively Recruiting
45
Qilu Hospital of Shandong University
Jinan, China, 250012
Actively Recruiting
46
The First Affiliated Hospital of NanChang University
Nanchang, China, 330006
Actively Recruiting
47
Zhongda Hospital Southeast University
Nanjing, China, 210009
Actively Recruiting
48
Institute of Hematology and Blood Diseases Hospital
Tianjin, China, 301609
Actively Recruiting
49
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
50
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
51
Henan Cancer Hospital
Zhengzhou, China, 450003
Actively Recruiting
52
Hopital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
53
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
54
CHU de Nantes hotel Dieu
Nantes, France, 44093
Actively Recruiting
55
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
56
Hopital trousseau- APHP
Paris, France, 75012
Actively Recruiting
57
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
Pessac, France, 33604
Completed
58
CHU Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
59
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
60
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
61
CHU Bretonneau
Tours, France, 37044
Actively Recruiting
62
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
63
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
64
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
65
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
66
Hadassah University Hospita Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
67
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
68
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
69
Kyushu University Hospital
Fukuoka, Japan, 812-0054
Active, Not Recruiting
70
Fukushima Medical University Hospital
Fukushima, Japan, 960 1295
Active, Not Recruiting
71
Kanazawa University Hospital
Kanazawa, Japan, 920 8641
Active, Not Recruiting
72
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Active, Not Recruiting
73
Kobe City Medical Center General Hospital
Kobe, Japan, 650 0047
Active, Not Recruiting
74
Gunmaken Saiseikai Maebashi Hospital
Maebashi, Japan, 371-0821
Active, Not Recruiting
75
Nagoya University Hospital
Nagoya, Japan, 466-8560
Completed
76
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Active, Not Recruiting
77
NTT Medical Center Tokyo
Tokyo, Japan, 141-8625
Active, Not Recruiting
78
Yamagata University Hospital
Yamagata, Japan, 990 2331
Actively Recruiting
79
University of Fukui Hospital
Yoshida, Japan, 910-1193
Completed
80
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
81
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
82
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
83
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
84
Hosp Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
85
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
86
Hospital Infantil Universitario Nino Jesus
Madrid, Spain, 28009
Actively Recruiting
87
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
88
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Actively Recruiting
89
Hosp Clinico Univ de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
90
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
91
Hosp. Clinico Univ. de Valencia
Valencia, Spain, 46010
Actively Recruiting
92
China Medical University Hospital
Taichung, Taiwan, 404327
Actively Recruiting
93
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
94
National Taiwan University Hospital
Taipei, Taiwan, 10043
Actively Recruiting
95
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
96
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
97
The Clatterbridge Cancer Centre
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
98
Guys and St Thomas NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
99
University College London Hospitals
London, United Kingdom, W1T 7HA
Actively Recruiting
100
The Christie Nhs Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
101
Oxford University Hospitals NHS Trust
Oxfordshire, United Kingdom, OX3 7LE
Actively Recruiting
102
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
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Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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