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NCT04603001 · ClinicalTrials.gov registry record · Phase 1

Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

A Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by Eli Lilly and Company.

Active
Registry status
Phase 1
Development phase
260
Enrollment target
20
Study locations

NCT04603001 is a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 260 participants, above the 136-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (91% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04603001, a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), is active but no longer recruiting, sponsored by Eli Lilly and Company.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
260 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

Conditions Studied

Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS) Chronic Myelomonocytic Leukemia (CMML) Myeloproliferative Neoplasms (MPNs)

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG LY3410738

Study Locations (20)

California

  • City of Hope National Medical Center - Duarte
  • UCLA Medical Center - Los Angeles
  • University of California, Davis - Health Systems - Sacramento

Illinois

  • Northwestern University - Chicago
  • University of Chicago Hospital - Chicago

New York

  • Roswell Park Cancer Institute - Buffalo
  • Memorial Sloan Kettering Cancer Center - New York

Victoria

  • Peter MacCallum Cancer Centre - Melbourne
  • The Alfred Hospital - Melbourne

Other

  • Cliniques universitaires Saint-Luc - Brussels
  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) - Helsinki

Florida

  • H Lee Moffitt Cancer Center - Tampa

Massachusetts

  • Massachusetts General Hospital - Boston

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2020-11-19
Est. Completion 2026-05
Phase Phase 1

Sponsor

Eli Lilly and Company

1,341 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04603001

The ClinicalTrials.gov registry entry for NCT04603001 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 136-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (91% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.

NCT04603001 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Illinois, New York.

Frequently Asked Questions

What is clinical trial NCT04603001 about?

NCT04603001 is a clinical study titled "Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations". This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

What is the current status of trial NCT04603001?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2020-11-19. Estimated completion is 2026-05.

What conditions does trial NCT04603001 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), Myeloproliferative Neoplasms (MPNs).

What interventions are being tested in trial NCT04603001?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), LY3410738 (DRUG).

Who is sponsoring clinical trial NCT04603001?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04603001 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.