Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Blood Cancer |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | May 2015 |
A Phase II Multi-center, Open Label, Randomized Study to Assess Safety and Efficacy of Two Different Schedules of Oral LDE225 in Adult Patients With Relapsed/Refractory or Untreated Elderly Patients With 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.
LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with
untreated acute leukemia.
Inclusion Criteria:
- 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 Criteria:
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
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