Actively Recruiting
A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)
Led by Sumitomo Pharma America, Inc. · Updated on 2026-03-24
606
Participants Needed
104
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in patients with acute leukemia.
CONDITIONS
Official Title
A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory AML, ALL, or acute leukemia of ambiguous lineage per WHO 2022, or selected sites with high-risk relapsed/refractory MDS or relapsed MM
- Patients with MDS must have bone marrow blasts ≥5% and relapsed or refractory disease after at least 2 cycles of hypomethylating agent treatment
- MM patients must have progressed after at least 3 prior regimens including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
- AML patients in venetoclax and azacitidine cohort must have MLL rearrangement or NPM1 mutation
- AML patients in gilteritinib cohort must have MLL rearrangement or NPM1 mutation plus specific FLT3 mutations
- Newly diagnosed AML patients must have MLL rearrangement or NPM1 mutation and no prior AML treatment except hydroxyurea
- Patients aged ≥18 years; in some sites, patients ≥12 years and ≥40 kg may enroll for DSP-5336 monotherapy
- ECOG performance status ≤2
- White blood cell count below 30,000/μL for monotherapy or below 25,000/μL for combination arms at enrollment
- Adequate kidney and liver function per protocol
- Prior toxicities resolved to grade 1 or less except alopecia or neuropathy
- Negative pregnancy test for females of childbearing potential and use of contraception by all men and women of childbearing potential
- Bone marrow material available for genomic analysis
- Willing to attend study visits and have an estimated life expectancy of at least 3 months
You will not qualify if you...
- Left ventricular ejection fraction less than 50%
- Diagnosis of acute promyelocytic leukemia
- Use of systemic calcineurin inhibitors within 2 weeks before first dose
- Clinically significant abnormal ECGs including prolonged QT interval
- Active uncontrolled infection requiring IV therapy
- Use of strong CYP3A4/5 inhibitors or inducers like ketoconazole or itraconazole
- Major surgery within 28 days before first dose
- Active central nervous system leukemia
- Hematopoietic stem cell transplant or CAR-T therapy within 60 days (6 months in UK)
- Donor lymphocyte infusion within 28 days or active graft-versus-host disease needing treatment
- Recent antineoplastic or investigational treatments within 7 days or 5 half-lives
- Significant concurrent medical conditions including severe heart, lung, or metabolic diseases
- Active HIV, hepatitis B or C infection
- Severe swallowing or absorption problems
- Cognitive or psychological conditions preventing study compliance
- Pregnant or breastfeeding women or planning pregnancy
- History of interstitial lung disease or significant drug-induced lung disease
- History of Torsades de Pointes arrhythmia
- Use of systemic calcineurin inhibitors within 4 weeks before first dose
- Plasma cell leukemia for MM patients
- Prior FLT3 inhibitor use in relapsed refractory setting for gilteritinib cohort
- Known hypersensitivity to study drugs
- Recent live vaccine within 30 days before first dose for DSP-5336 plus venetoclax/azacitidine arm in UK
AI-Screening
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Trial Site Locations
Total: 104 locations
1
Hoag Family Cancer Center
Newport Beach, California, United States, 92663
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Not Yet Recruiting
3
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
4
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Miami Cancer Institute
Miami, Florida, United States, 33176
Not Yet Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
8
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Sibley Memorial Hospital
Baltimore, Maryland, United States, 20016
Actively Recruiting
10
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
11
Johns Hopkins Main Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
12
Tufts University
Boston, Massachusetts, United States, 02111
Withdrawn
13
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
Atlantic Health
Morristown, New Jersey, United States, 07960
Actively Recruiting
15
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
16
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
Actively Recruiting
17
Mount Sinai Hospital
New York, New York, United States, 10029
Completed
18
Columbia University
New York, New York, United States, 10032
Completed
19
UNC Hospital
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
20
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
21
Atrium Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
22
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
23
Oncology Associates of Oregon
Eugene, Oregon, United States, 97401
Actively Recruiting
24
Sidney Kimmel Comprehensive Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
25
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
26
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
27
TriStar Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
28
MDACC
Houston, Texas, United States, 77030
Actively Recruiting
29
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
30
Intermountain Healthcare
Salt Lake City, Utah, United States, 84143
Actively Recruiting
31
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
32
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
33
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
34
ZNA Cadix
Antwerp, Belgium
Actively Recruiting
35
UZ Ghent
Ghent, Belgium, 9000
Actively Recruiting
36
University Hospitals Leuven
Leuven, Belgium
Actively Recruiting
37
AZ Delta
Roeselare, Belgium
Actively Recruiting
38
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
39
University of Alberta
Edmonton, Canada, T6G 2R3
Actively Recruiting
40
Centre Hospitalier Universitaire d'Angers
Angers, France
Actively Recruiting
41
Hopital Avicenne
Bobigny, France, 93000
Not Yet Recruiting
42
Centre Hospitalier Le Mans
Le Mans, France
Actively Recruiting
43
Hopital Claude Huriez
Lille, France, 59037
Not Yet Recruiting
44
Centre Hospitalier Universitaire de Limoges
Limoges, France
Actively Recruiting
45
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
46
Institut Paoli-Calmettes
Marseille, France
Actively Recruiting
47
CHU de Nantes
Nantes, France, 44093
Not Yet Recruiting
48
CHU de Nice - Hôpital l'Archet 1
Nice, France
Actively Recruiting
49
Hopital Saint-Louis
Paris, France
Actively Recruiting
50
CHU Bordeaux
Talence, France, 33000
Not Yet Recruiting
51
Institut Gustave Roussy
Villejuif, France, 94800
Not Yet Recruiting
52
IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Policlinico Sant'Orsola
Bologna, Italy
Actively Recruiting
53
Ospedale di Busto Arsizio
Busto Arsizio, Italy, 21052
Not Yet Recruiting
54
Ospedale Policlinico San Martino, IRCCS
Genoa, Italy
Actively Recruiting
55
IRCCS istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Italy
Actively Recruiting
56
Istituto Oncologico Veneto (IOV), IRCCS
Padua, Italy
Not Yet Recruiting
57
Università degli Studi di Perugia
Perugia, Italy
Actively Recruiting
58
Azienda USL della Romagna, Ospedale Santa Maria delle Croci di Ravenna
Ravenna, Italy, 48121
Not Yet Recruiting
59
PU A. Gemelli, Università Cattolica del Sacro Cuore
Rome, Italy
Actively Recruiting
60
Universita' Degli Studi Di Torino
Turin, Italy
Actively Recruiting
61
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
62
University of Fukui Hospital
Yoshida-gun, Fukui, Japan, 910-1193
Actively Recruiting
63
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan, 960-1295
Actively Recruiting
64
Tokai University Hospital
Isehara-shi, Kanagawa, Japan, 259-1193
Actively Recruiting
65
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan, 852-8501
Actively Recruiting
66
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
67
Tokyo Metropolitan Komagome Hospital
Bunkyō City, Japan, 113-8677
Not Yet Recruiting
68
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
69
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
Not Yet Recruiting
70
Tohoku University Hospital
Miyagi, Japan, 980-8574
Actively Recruiting
71
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
72
Osaka University Hospital
Osaka, Japan, 565-0871
Actively Recruiting
73
National University Cancer Institute
Singapore, Singapore, 119074
Actively Recruiting
74
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Actively Recruiting
75
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
76
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
77
The Catholic University of Korea
Seoul, South Korea
Actively Recruiting
78
Hospital General Universitario De Albacete
Albacete, Spain
Actively Recruiting
79
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Actively Recruiting
80
Institut Catala d'Oncologia
Barcelona, Spain
Actively Recruiting
81
Hospital San Pedro de Alcantara
Cáceres, Spain
Actively Recruiting
82
Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas, Spain
Actively Recruiting
83
MD Anderson Cancer Center
Madrid, Spain
Actively Recruiting
84
Hospital Universitario Central De Asturias
Oviedo, Spain
Actively Recruiting
85
Hospital Universitario de Salamanca
Salamanca, Spain
Actively Recruiting
86
Fundacion Instituto de Investigacion Marques de Valdecilla
Santander, Spain
Actively Recruiting
87
Complexo Hospitalario Universitario De Santiago
Santiago de Compostela, Spain
Actively Recruiting
88
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Actively Recruiting
89
University Hospital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
90
University Hospital Bern Inselspital
Bern, Switzerland, 3010
Not Yet Recruiting
91
Universitaetsspital Zuerich - Haematology
Zurich, Switzerland, 8091
Not Yet Recruiting
92
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
93
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
94
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
95
University Hospitals of Birmingham Centre for Clinical Hematology
Birmingham, United Kingdom
Actively Recruiting
96
Bristol Hematology & Oncology Centre
Bristol, United Kingdom
Actively Recruiting
97
NHS Lothian Western General
Edinburgh, United Kingdom, EH4 2XU
Not Yet Recruiting
98
King's College Hospital
London, United Kingdom
Actively Recruiting
99
Sarah Cannon Research Institute
London, United Kingdom
Not Yet Recruiting
100
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Actively Recruiting
101
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
102
Churchill Hospital Oxford
Oxford, United Kingdom
Not Yet Recruiting
103
University Hospitals of North Midlands NHS Foundation Trust
Stoke-on-Trent, United Kingdom
Not Yet Recruiting
104
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Actively Recruiting
Research Team
M
Matt Hitron, MD
CONTACT
T
Tomoko Kuwabara
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
14
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