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NCT01826214 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT01826214: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01826214 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01826214, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
The study will evaluate the efficacy, safety and tolerability of two dosing schedules of LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated acute leukemia.
Primary Outcome
Complete Response (CR) was based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CR. A treatment cycle was defined as 4 weeks. The outcome measure for the study is based on standardized response criteria as defined by the International Working Group (IWG) for AML. The IWG was established by a group of investigators interested in the design and condu
Interventions
- DRUG LDE225
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT01826214 record still lists
NCT01826214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which LDE225 is the first listed.
NCT01826214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01826214 about?
NCT01826214 is a clinical study titled "Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia". The study will evaluate the efficacy, safety and tolerability of two dosing schedules of LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated acute leukemia.
What is the current status of trial NCT01826214?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2013-05. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01826214?
The interventions under investigation include: LDE225 (DRUG).
Who is sponsoring clinical trial NCT01826214?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01826214's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 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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