Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03258931 · ClinicalTrials.gov registry record · Phase 3
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
A Phase 3 study, sponsored by Arog Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT03258931: Completed Phase 3 study, sponsored by Arog Pharmaceuticals.
NCT03258931 is a Phase 3 study that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03258931, a Phase 3 study, has completed, sponsored by Arog Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
Study Summary
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.
Interventions
- DRUG Cytarabine
- DRUG Midostaurin
- DRUG Crenolanib
- DRUG Duanorubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2018-08-15 |
| Est. Completion | 2026-04-06 |
| Phase | Phase 3 |
What the finished NCT03258931 record still lists
NCT03258931 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which Cytarabine is the first listed.
NCT03258931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03258931 about?
NCT03258931 is a clinical study titled "Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML". A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will...
What is the current status of trial NCT03258931?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2018-08-15. Estimated completion is 2026-04-06.
What interventions are being tested in trial NCT03258931?
The interventions under investigation include: Cytarabine (DRUG), Midostaurin (DRUG), Crenolanib (DRUG), Duanorubicin (DRUG).
Who is sponsoring clinical trial NCT03258931?
This trial is sponsored by Arog Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03258931's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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
- NCT04030507 · 214 participants · NA
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
- NCT04421248 · 214 participants · Phase 4
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
- NCT04667520 · 214 participants · NA
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
- NCT05418868 · 214 participants · Phase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
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