Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia

Completed · Phase 2

Conditions studied: Acute Leukemias

In brief

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.

Key facts

Study ID

NCT01826214

Run by

Novartis Pharmaceuticals

People needed

70

Starts

2013-05-01

Expected to finish

2015-05-01

Last updated by the study team

2016-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center SC-5 — Durham, North Carolina, United States
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — Prahran, Victoria, Australia
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Yvoir, Belgium
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Magdeburg, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Nijmegen, Netherlands
• Novartis Investigative Site — Rotterdam, Netherlands
• Novartis Investigative Site — Rotterdam, Netherlands
• Novartis Investigative Site — Bergen, Norway
• Novartis Investigative Site — Trondheim, Norway
• Novartis Investigative Site — Salamanca, Castille and León, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain
• Novartis Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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