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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 is a Phase 3 study that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 214 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03258931
The ClinicalTrials.gov registry entry for NCT03258931 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arog Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cytarabine is the first listed.
NCT03258931 reports 0 study locations.
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.
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