Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
Completed · Phase 2
Conditions studied: Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia
In brief
To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).
Key facts
- Study ID
- NCT01844765
- Run by
- Novartis Pharmaceuticals
- People needed
- 59
- Starts
- 2013-08-20
- Expected to finish
- 2020-08-28
- Last updated by the study team
- 2021-04-22
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Loma Linda University Cancer Center — Loma Linda, California, United States
- Lucile Salter Packard Children's Hospital at Stanford — Palo Alto, California, United States
- Nemours Childrens Hospital — Orlando, Florida, United States
- St. Mary's Hospital — West Palm Beach, Florida, United States
- Johns Hopkins Oncology Center ORA — Baltimore, Maryland, United States
- UNC Chapel Hill — Chapel Hill, North Carolina, United States
- Nationwide Childrens Hospital — Columbus, Ohio, United States
- University of Texas Southwestern Medical Center Oncology — Dallas, Texas, United States
- Cook Children's Medical Center Oncology — Fort Worth, Texas, United States
- Seattle Childrens Hospital — Seattle, Washington, United States
- Novartis Investigative Site — Bordeaux, Aquitaine, France
- Novartis Investigative Site — Lille, France
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Poitiers, France
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Genova, GE, Italy
- Novartis Investigative Site — Monza, MB, Italy
- Novartis Investigative Site — Padova, PD, Italy
- Novartis Investigative Site — Torino, TO, Italy
- Novartis Investigative Site — Yokohama, Kanagawa, Japan
- Novartis Investigative Site — Sakyo Ku, Kyoto, Japan
- Novartis Investigative Site — Shinjuku-ku, Tokyo, Japan
- Novartis Investigative Site — Saitama, Japan
- Novartis Investigative Site — Shizuoka, Japan
- Novartis Investigative Site — Kuala Lumpur, Malaysia
Full record on ClinicalTrials.gov
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