Actively Recruiting
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
420
Participants Needed
103
Research Sites
487 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Phase 1 pediatric cohort: Age 2 years to less than 18 years; for all other cohorts: 18 years and older
- Have relapsed or refractory acute leukemia and have exhausted or are ineligible for available treatment options
- Acute leukemia with gene alterations in KMT2A, NPM1, or NUP98/NUP214
- For Phase 2: Adults over 18 years with relapsed/refractory acute myeloid leukemia diagnosed by WHO 2022 criteria
- AML must have KMT2A rearrangement or NPM1 mutations
- Pretreatment lab values: WBC count ≤ 20 x 10^9/L; adults with kidney function (GFR) ≥ 30 mL/min; children with kidney function (GFR) ≥ 40 mL/min
- ECOG performance status 0, 1, or 2; pediatric participants must have Lansky scale ≥ 70 if under 16 or Karnofsky scale ≥ 70 if 16 or older
- Females of childbearing potential must have a negative pregnancy test at screening and within 48 hours before first dose
- Agree to contraception requirements and avoid sperm or egg donation or freezing during and for specified time 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 ≥ 450 msec for males or ≥ 470 msec for females or family history of Long QT syndrome
- Stem cell transplant within 3 months before first dose, graft versus host disease, donor lymphocyte infusion within 1 month, or need for immunosuppressive therapy beyond low-dose steroids
- Prior cancer immunotherapy within 4 weeks or blinatumomab within 2 weeks before enrollment
- Other cancer therapies within 4 weeks or 5 half-lives before enrollment, whichever is shorter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 103 locations
1
City of Hope Phoenix
Goodyear, Arizona, United States, 85338
Terminated
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
University of California Irvine Medical Center
Orange, California, United States, 92868
Completed
4
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
5
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
Actively Recruiting
8
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Completed
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
10
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201 2013
Actively Recruiting
12
Start Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
13
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
14
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
15
NYU Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
16
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
17
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
18
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
19
Maine Health
Providence, Rhode Island, United States, 02903
Actively Recruiting
20
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
21
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
22
Houston Methodist Hospital
Houston, Texas, United States, 77030-2740
Actively Recruiting
23
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
24
San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas, United States, 78229
Actively Recruiting
25
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
26
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
27
Medical College of WI at Froedtert
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
28
Monash Medical Centre
Clayton, Australia, 3168
Actively Recruiting
29
Royal Perth Hospital
Perth, Australia, 6000
Actively Recruiting
30
Gold Coast University Hospital
Southport, Australia, 4211
Actively Recruiting
31
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
32
Instituto D Or de Pesquisa e Ensino
Brasília, Brazil, 70390 700
Actively Recruiting
33
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59062 000
Actively Recruiting
34
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, Brazil, 20230 130
Actively Recruiting
35
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil, 01246 000
Actively Recruiting
36
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, Brazil, 01401 002
Actively Recruiting
37
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil, 01509 900
Actively Recruiting
38
Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
39
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada, M5G 1X6
Actively Recruiting
40
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
41
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
42
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
43
West China Hospital Si Chuan University
Chengdu, China, 610041
Actively Recruiting
44
Nanfang Hospital of Southern Medical Hospital
Guangzhou, China, 510515
Actively Recruiting
45
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, China, 310009
Actively Recruiting
46
Qilu Hospital of Shandong University
Jinan, China, 250012
Actively Recruiting
47
The First Affiliated Hospital of NanChang University
Nanchang, China, 330006
Actively Recruiting
48
Zhongda Hospital Southeast University
Nanjing, China, 210009
Actively Recruiting
49
Institute of Hematology and Blood Diseases Hospital
Tianjin, China, 301609
Actively Recruiting
50
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
51
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
52
Henan Cancer Hospital
Zhengzhou, China, 450003
Actively Recruiting
53
Hopital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
54
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
55
CHU de Nantes hotel Dieu
Nantes, France, 44093
Actively Recruiting
56
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
57
Hopital trousseau- APHP
Paris, France, 75012
Actively Recruiting
58
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
Pessac, France, 33604
Completed
59
CHU Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
60
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
61
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
62
CHU Bretonneau
Tours, France, 37044
Actively Recruiting
63
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
64
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
65
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
66
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
67
Hadassah University Hospita Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
68
Sheba Medical Center
Ramat Gan, Israel, 52621
Actively Recruiting
69
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
70
Kyushu University Hospital
Fukuoka, Japan, 812-0054
Active, Not Recruiting
71
Fukushima Medical University Hospital
Fukushima, Japan, 960 1295
Active, Not Recruiting
72
Kanazawa University Hospital
Kanazawa, Japan, 920 8641
Active, Not Recruiting
73
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Active, Not Recruiting
74
Kobe City Medical Center General Hospital
Kobe, Japan, 650 0047
Active, Not Recruiting
75
Gunmaken Saiseikai Maebashi Hospital
Maebashi, Japan, 371-0821
Active, Not Recruiting
76
Nagoya University Hospital
Nagoya, Japan, 466-8560
Completed
77
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Active, Not Recruiting
78
NTT Medical Center Tokyo
Tokyo, Japan, 141-8625
Active, Not Recruiting
79
Yamagata University Hospital
Yamagata, Japan, 990 2331
Completed
80
University of Fukui Hospital
Yoshida, Japan, 910-1193
Completed
81
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
82
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
83
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
84
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
85
Hosp Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
86
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
87
Hospital Infantil Universitario Nino Jesus
Madrid, Spain, 28009
Actively Recruiting
88
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
89
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Actively Recruiting
90
Hosp Clinico Univ de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
91
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
92
Hosp. Clinico Univ. de Valencia
Valencia, Spain, 46010
Actively Recruiting
93
China Medical University Hospital
Taichung, Taiwan, 404327
Actively Recruiting
94
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
95
National Taiwan University Hospital
Taipei, Taiwan, 10043
Actively Recruiting
96
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
97
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
98
The Clatterbridge Cancer Centre
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
99
Guys and St Thomas NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
100
University College London Hospitals
London, United Kingdom, W1T 7HA
Actively Recruiting
101
The Christie Nhs Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
102
Oxford University Hospitals NHS Trust
Oxfordshire, United Kingdom, OX3 7LE
Actively Recruiting
103
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
S
Study Contact
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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