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NCT02283177 · ClinicalTrials.gov registry record · Phase 2
A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations
A Phase 2 study, sponsored by Arog Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT02283177: Completed Phase 2 study, sponsored by Arog Pharmaceuticals.
NCT02283177 is a Phase 2 study that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02283177, a Phase 2 study, has completed, sponsored by Arog Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations.
Primary Outcome
To determine the response rate to crenolanib. Complete remission (CR) response criteria includes a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, the absence of Auer rods and extramedullary leukemia, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. Complete remission with incomplete blood count recovery (CRi) response includes all CR criteria met, except participant do not achieve either platelet or ANC recovery. Composite Complete CR response inc
Interventions
- DRUG cytarabine
- DRUG daunorubicin
- DRUG idarubicin
- DRUG crenolanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-01 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
What the finished NCT02283177 record still lists
NCT02283177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 4 interventions - of which cytarabine is the first listed.
NCT02283177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02283177 about?
NCT02283177 is a clinical study titled "A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations". This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations.
What is the current status of trial NCT02283177?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2015-01. Estimated completion is 2019-12.
What interventions are being tested in trial NCT02283177?
The interventions under investigation include: cytarabine (DRUG), daunorubicin (DRUG), idarubicin (DRUG), crenolanib (DRUG).
Who is sponsoring clinical trial NCT02283177?
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 NCT02283177's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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