Status:
COMPLETED
Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Leukemias
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Subjects must have relapsed or primary refractory non-M3 acute myeloid leukemia or relapsed or refractory non-T-cell acute lymphoblastic leukemia or untreated acute myeloid leukemia in elderly patients.
- Performance status of 0, 1 or 2 per WHO classification.
- Adequate renal and liver function.
- Adequate blood creatine kinase value (CK \< 1.5ULN)
Exclusion
- Allogeneic stem cell transplantation within the last 4 months and/or active graft versus host disease requiring systemic immunosuppressant therapy, or autologous stem cell transplantation within the last 4 weeks.
- Patient for which immediate allogeneic stem cell transplantation is the treatment of choice.
- Pregnant or nursing (lactating) women.
- Active CNS leukemic involvement
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01826214
Start Date
May 1 2013
End Date
May 1 2015
Last Update
August 30 2016
Active Locations (23)
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1
Duke University Medical Center SC-5
Durham, North Carolina, United States, 27710
2
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
3
Novartis Investigative Site
Prahran, Victoria, Australia, 3181
4
Novartis Investigative Site
Salzburg, Austria, 5020