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NCT01522469 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations
A Phase 2 study, sponsored by Arog Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT01522469: Completed Phase 2 study, sponsored by Arog Pharmaceuticals.
NCT01522469 is a Phase 2 study that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01522469, a Phase 2 study, has completed, sponsored by Arog Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a Phase II open label study of crenolanib besylate. This study will enroll subjects with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other FLT3 TKIs is allowed. Subjects will take crenolanib 200mg/m2/day divided in three doses daily (preferably every eight hours), taken orally at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who are able to proceed to allogeneic stem cell transplant will be able to resume crenolanib therapy post-transplant in an attempt to maintain remission.
Primary Outcome
To determine the response rate to crenolanib.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 but \>5%. Hematologic
Interventions
- DRUG Crenolanib Besylate (CP-868,596-26)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01522469 record still lists
NCT01522469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Crenolanib Besylate (CP-868,596-26) is the first listed.
NCT01522469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01522469 about?
NCT01522469 is a clinical study titled "Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations". This is a Phase II open label study of crenolanib besylate. This study will enroll subjects with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other FLT3 TKIs is allowed. Subjects will take crenolanib 200mg/m2/day divided in three doses daily (preferably every eight...
What is the current status of trial NCT01522469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2012-07. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01522469?
The interventions under investigation include: Crenolanib Besylate (CP-868,596-26) (DRUG).
Who is sponsoring clinical trial NCT01522469?
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 NCT01522469's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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