Status:
COMPLETED
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
The study was designed as a multi-center, open-label, non-controlled phase II study to assess efficacy, safety and PK parameters of 230 mg/m2 twice daily nilotinib in pediatric patients (1 to \<18 yea...
Eligibility Criteria
Inclusion
- Key
- Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib
- Karnofsky ≥ 50% for patients \> 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age
- Adequate renal, hepatic and pancreatic function
- Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal)
- Written informed consent
- Key
Exclusion
- Treatment with strong CYP3A4 inhibitors or inducers
- Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval
- Acute or chronic liver, pancreatic or severe renal disease
- History of pancreatitis or chronic pancreatitis.
- Impaired cardiac function
- No evidence of active graft vs host and \<3mo since Stem Cell Transplant
- Total body irradiation (TBI) or craniospinal radiation therapy \<6months
- Hypersensitivity to the active ingredient or any of the excipients including lactose.
- the criteria regarding pregnancy and contraception
- Active or systemic bacterial, fungal, or viral infection
- known Hepatitis B, Hepatitis C, or HIV infection
Key Trial Info
Start Date :
August 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01844765
Start Date
August 20 2013
End Date
August 28 2020
Last Update
April 22 2021
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Loma Linda University Cancer Center
Loma Linda, California, United States, 92350
2
Lucile Salter Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
3
Nemours Childrens Hospital
Orlando, Florida, United States, 32827
4
St. Mary's Hospital
West Palm Beach, Florida, United States, 33407