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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Leukemias

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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 2New York, New York  10021
Medical University of South Carolina MUSCCharleston, South Carolina  29425
Duke University Medical Center SC-5Durham, North Carolina  27710
Stanford University Medical Center SC - 5Stanford, California  94304
Dana Farber Cancer Institute Regulatory - 9Boston, Massachusetts  02115