Trials / Terminated
TerminatedNCT01131325
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
A Multi-center, Single Arm Study of Nilotinib in Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Patients With Low Imatinib Trough Plasma Concentrations
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.
Conditions
- CML
- Philadelphia Chromosome Positive (Ph+)
- Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nilotinib | All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours |
Timeline
- Start date
- 2010-10-21
- Primary completion
- 2011-05-12
- Completion
- 2011-05-12
- First posted
- 2010-05-26
- Last updated
- 2021-05-20
- Results posted
- 2021-05-20
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01131325. Inclusion in this directory is not an endorsement.