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NCT01657682 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
A Phase 2 study, sponsored by Arog Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT01657682: Completed Phase 2 study, sponsored by Arog Pharmaceuticals.
NCT01657682 is a Phase 2 study that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01657682, a Phase 2 study, has completed, sponsored by Arog Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This pilot Phase II study is designed to evaluate the efficacy and tolerability of crenolanib in two cohorts of AML patients with FLT3 activation mutations (patients whose leukemia has recurred after prior chemotherapy not including a FLT3 TKI and patients whose leukemia has progressed after prior therapy with a FLT3 TKI).
Primary Outcome
To determine the response rate to crenolanib. CR Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. CRi response included all CR criteria met, except participant did not experience either platelet recovery or ANC recovery. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline to a post-baselin
Interventions
- DRUG Crenolanib besylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-10 |
| Est. Completion | 2019-04 |
| Phase | Phase 2 |
What the finished NCT01657682 record still lists
NCT01657682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Crenolanib besylate is the first listed.
NCT01657682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01657682 about?
NCT01657682 is a clinical study titled "A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations". This pilot Phase II study is designed to evaluate the efficacy and tolerability of crenolanib in two cohorts of AML patients with FLT3 activation mutations (patients whose leukemia has recurred after prior chemotherapy not including a FLT3 TKI and patients whose leukemia has progressed after prior t...
What is the current status of trial NCT01657682?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2012-10. Estimated completion is 2019-04.
What interventions are being tested in trial NCT01657682?
The interventions under investigation include: Crenolanib besylate (DRUG).
Who is sponsoring clinical trial NCT01657682?
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 NCT01657682's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 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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