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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 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.

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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.

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

168 total trials

What the Registry Record Tells You About NCT04988555

The ClinicalTrials.gov registry entry for NCT04988555 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 104-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (248% higher). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.