A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia

Stopped early · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

In brief

This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients \<18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.

Key facts

Study ID

NCT00866281

Run by

Novartis Pharmaceuticals

People needed

22

Starts

2009-09-01

Expected to finish

2014-09-01

Last updated by the study team

2015-12-22

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mixed-lineage leukemia (MLL) gene rearranged Acute Lymphoblastic Leukemia (ALL), that does not respond to treatment or has relapsed from prior treatment; or FLT3 mutated Acute Myeloid Leukemia (AML) that does not respond to a second treatment or has relapsed from 2 prior treatments
• Normal organ function, and chest x-ray
• Expected survival greater than 8 weeks
• Can care for most of personal needs and perform at least minimum activity

You may not qualify if…

• Patients with symptomatic leukemic central nervous system involvement or isolated extramedullary leukemia
• Patients must not have received other treatments for leukemia within a predefined time period, 72 hours for medications, 2 months for transplants
• Patients with heart function that is not normal
• Patients with HIV or hepatitis
• Patients with another severe disease or medical condition besides leukemia Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Seattle Children's Hospital CPKC412A2114 — Seattle, Washington, United States
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Genova, GE, Italy
• Novartis Investigative Site — Monza, MB, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Torino, TO, Italy
• Novartis Investigative Site — Rotterdam, Netherlands
• Novartis Investigative Site — Stockholm, Sweden

Full record on ClinicalTrials.gov

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