Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation

NCT04988555 · View on ClinicalTrials.gov ↗

Study Summary

A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in adult patients with acute leukemia.

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

FieldValue
Enrollment Target 362 participants
Start Date 2022-02-28
Est. Completion 2027-10-31
Phase Phase 1

Sponsor

Sumitomo Pharma America

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04988555

The ClinicalTrials.gov registry entry for NCT04988555 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04988555 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Maryland, New York, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04988555?

The interventions under investigation include: Venetoclax (DRUG), Gilteritinib (DRUG), Azacitidine (AZA) (DRUG), Enzomenib (DRUG), azoles (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04988555?

This trial is sponsored by Sumitomo Pharma America, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial