Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
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A Non-randomized, Open-label Study to Characterize the Pharmacokinetics (PK) 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 (HES, CEL, MDS/ MPN)
Study Start Date :
Actual Primary Completion Date :
Resource links provided by the National Library of Medicine
Measure: Pharmacokinetic data o (CL/F (clearance) o V/F (Volume of distribution) o Tmax o Physiologically based pharmacokinetic (PBPK) parameters (plasma protein binding and α-1 acid glycoprotein concentration) [ Time Frame: 2 PK sample collection within 21 days ]
Secondary Outcome Measures :
safety and tolerability of imatinib during the study period [ Time Frame: study period of 21 days ]
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Ages Eligible for Study:
1 Year to 3 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must be 1 to less than 4 years of age at study entry
Written informed consent must be signed by the patient's parent or legal guardian.
Patients must have the diagnosis of CML or Ph+ ALL
Lansky score must be ≥ 50 (Table7-2)
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
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)
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)
Patients receiving antibacterial and antipyretic medication to treat active infection
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
Patients whose parents or legal guardians, in the opinion of the Investigator, were unlikely to comply with the protocol or safety monitoring requirements
Other protocol-defined inclusion/exclusion criteria may apply