Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by Eli Lilly and Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
For Dose Escalation
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What the registry record for NCT04603001 still lists
NCT04603001 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 136-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (91% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia (AML)
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.
Where NCT04603001's enrollment target sits among peer trials
260 4th of 29 higher than 26 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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
-
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
RECRUITING · Phase 1
-
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
RECRUITING · Phase 1
-
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
RECRUITING · Phase 1
-
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
RECRUITING · Phase 1
-
A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
RECRUITING · Phase 1
-
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02283996 · 260 participants · Phase 4
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
- NCT03276793 · 260 participants · NA
Brain Connectivity in Depression
- NCT03407469 · 260 participants
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
- NCT03713125 · 260 participants · NA
Executive Function in Early Childhood
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI