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
18 Years
N/A
Both
Acute Leukemias
Trial Information
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
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, or autologous stem cell transplantation within the last 4 weeks.
- Pregnant or nursing (lactating) women.
- Active CNS leukemic involvement
- Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
Outcome Description:
The primary efficacy endpoint is the rate of CR and CRi based on the International Working Group (IWG) criteria. Patients with acute leukemia will be randomized into one of two different dosing schedules of LDE225. Efficacy assessments will be performed to determine CR/CRi: every 8 weeks for 6 months post CR, and every 12 weeks thereafter.
Outcome Time Frame:
Screening to 20 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CLDE225X2203
NCT ID:
NCT01826214
Start Date:
May 2013
Completion Date:
February 2015
Related Keywords:
- Acute Leukemias
- acute myeloid leukemia, acute lymphoblastic leukemia, leukemia, acute
- Leukemia
- Acute Disease
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center Sloan Kettering 2 | New York, New York 10021 |
| Medical University of South Carolina MUSC | Charleston, South Carolina 29425 |
| Duke University Medical Center SC-5 | Durham, North Carolina 27710 |
| Stanford University Medical Center SC - 5 | Stanford, California 94304 |
| Dana Farber Cancer Institute Regulatory - 9 | Boston, Massachusetts 02115 |
