A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)
Public ClinicalTrials.gov record NCT04988555. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia and Other Selected Hematologic Malignancies, With and Without Mixed Lineage Leukemia (MLL) Rearrangement or Nucleophosmin 1 (NPM1) Mutation (Horizen-1)
Study identification
- NCT ID
- NCT04988555
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Industry
- Enrollment
- 606 participants
Conditions and interventions
Conditions
Interventions
- Azacitidine (AZA) Drug
- Enzomenib Drug
- Gilteritinib Drug
- Intensive chemotherapy with 7 + 3 Drug
- Venetoclax Drug
- azoles Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 27, 2022
- Primary completion
- Jun 29, 2027
- Completion
- Dec 30, 2027
- Last update posted
- Mar 23, 2026
2022 – 2027
United States locations
- U.S. sites
- 33
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hoag Family Cancer Center | Newport Beach | California | 92663 | Recruiting |
| Stanford University | Palo Alto | California | 94304 | Not yet recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | Recruiting |
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | Not yet recruiting |
| University of Miami | Miami | Florida | 33136 | Recruiting |
| Miami Cancer Institute | Miami | Florida | 33176 | Not yet recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Not yet recruiting |
| Northwestern | Chicago | Illinois | 60611 | Recruiting |
| Sibley Memorial Hospital | Baltimore | Maryland | 20016 | Recruiting |
| University of Maryland | Baltimore | Maryland | 21201 | Recruiting |
| Johns Hopkins Main Center | Baltimore | Maryland | 21287 | Recruiting |
| Tufts University | Boston | Massachusetts | 02111 | Withdrawn |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Atlantic Health | Morristown | New Jersey | 07960 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | Recruiting |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14203 | Recruiting |
| Mount Sinai Hospital | New York | New York | 10029 | Completed |
| Columbia University | New York | New York | 10032 | Completed |
| UNC Hospital | Chapel Hill | North Carolina | 27514 | Recruiting |
| Duke University | Durham | North Carolina | 27705 | Recruiting |
| Atrium Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | Recruiting |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| Oncology Associates of Oregon | Eugene | Oregon | 97401 | Recruiting |
| Sidney Kimmel Comprehensive Cancer Center | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| TriStar Centennial Medical Center | Nashville | Tennessee | 37203 | Recruiting |
| MDACC | Houston | Texas | 77030 | Recruiting |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | Recruiting |
| Intermountain Healthcare | Salt Lake City | Utah | 84143 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22908 | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04988555, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 23, 2026 · Synced Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04988555 live on ClinicalTrials.gov.