A non-randomized, open-label study to characterize the pharmacokinetcs of Glivec/Gleevec (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) or other Glivec/Gleevec® indicated hematological disorders.
- Conditions
- Chronic Myeloid Leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia10024324
- Registration Number
- NL-OMON34200
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
1. Patients must be 1 to less than 4 years of age at study entry.
2. Written informed consent must be signed by the patient*s parent or legal guardian.
3. Patients must have the diagnosis of CML or Ph+ ALL or other imatinib indicated hematological disorders.
4. Lansky score must be >= 50
5. Patient must have adequate end organ function as defined by
• Total bilirubin < 1.5 x ULN
• SGPT (ALT) and SGOT (AST) < 2.5 x UNL
• Creatinine < 1.5 x ULN
1. Patients who have received drugs a) known to be metabolized by CYP3A4 or 3A5, b) are CYP inhibitors and inducers, within 2 weeks prior to Visit 2 (except for imatinib)
2. Patients who previously received radiotherapy to >= 25% of the bone marrow, with the
exception of patients who received total body radiation as part of a preparatory regimen
for hematopoetic stem cell transplant (HSCT)
3. Patients receiving antibacterial and antipyretic medication to treat active infection
4. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
5. Patients whose parents or legal guardian, in the opinion of the investigator, are unlikely to comply with the protocol or safety monitoring requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic data:<br /><br>* CL/F<br /><br>* V/F<br /><br>* Tmax<br /><br>* PBPK parameters<br /><br>* Cmax<br /><br>* AUC</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety and tolerability of imatinib during the study period (including<br /><br>recording of adverse events and serious adverse events, monitoring hematology<br /><br>and blood chemistry, measurement of vital signs and performance of physical<br /><br>examinations, documentation of concomitant medication and therapies). </p><br>