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NCT04988555 · ClinicalTrials.gov registry record · Phase 1
A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation
A Phase 1 study of Leukemia, Myeloid, Acute and Leukemia, Lymphocytic, Acute, sponsored by Sumitomo Pharma America.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 362
- Enrollment target
- 20
- Study locations
NCT04988555: Recruiting Phase 1 study of Leukemia, Myeloid, Acute and Leukemia, Lymphocytic, Acute, sponsored by Sumitomo Pharma America.
NCT04988555 is a Phase 1 study of Leukemia, Myeloid, Acute and Leukemia, Lymphocytic, Acute that is actively recruiting participants, run by Sumitomo Pharma America. The registered enrollment target is 362 participants, above the 104-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (248% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04988555, a Phase 1 study of Leukemia, Myeloid, Acute and Leukemia, Lymphocytic, Acute, is actively recruiting participants, sponsored by Sumitomo Pharma America.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 362 participants
- Enrollment target
- 20
- Study locations
Study Summary
A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in adult patients with acute leukemia.
Primary Outcome
Assessment of safety of DSP-5336 administered in participants with advanced hematologic malignancies by reporting of adverse events and serious adverse events in Phase 1
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Gilteritinib
- DRUG Azacitidine (AZA)
- DRUG Enzomenib
- DRUG azoles
Study Locations (20)
Maryland
- Sibley Memorial Hospital - Baltimore
- University of Maryland - Baltimore
- Johns Hopkins Main Center - Baltimore
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Mount Sinai Hospital - New York
- Columbia University - New York
North Carolina
- UNC Hospital - Chapel Hill
- Duke University - Durham
- Atrium Wake Forest Baptist Medical Center - Winston-Salem
Massachusetts
- Tufts University - Boston
- Massachusetts General Hospital - Boston
New Jersey
- Atlantic Health - Morristown
- Rutgers Cancer Institute of New Jersey - New Brunswick
California
- Hoag Family Cancer Center - Newport Beach
Colorado
- Colorado Blood Cancer Institute - Denver
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2022-02-28 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 1 |
What NCT04988555 shows while recruiting
NCT04988555 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, above the 104-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (248% higher).
The record links to 2 conditions, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT04988555 names 20 study sites across 12 states, led by Maryland, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04988555 about?
NCT04988555 is a clinical study titled "A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation". A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in adult patients with acute leukemia.
What is the current status of trial NCT04988555?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 362 participants. The study started on 2022-02-28. Estimated completion is 2027-10-31.
What conditions does trial NCT04988555 study?
This clinical trial studies the following conditions: Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute.
What interventions are being tested in trial NCT04988555?
The interventions under investigation include: Venetoclax (DRUG), Gilteritinib (DRUG), Azacitidine (AZA) (DRUG), Enzomenib (DRUG), azoles (DRUG).
Who is sponsoring clinical trial NCT04988555?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04988555 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04988555's enrollment target sits among peer trials
362 2nd of 30 the highest of 30 other Leukemia, Myeloid, Acute trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia, Myeloid, Acute trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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