Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.

Study Overview
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Brief Summary
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This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4 years of age to help develop dosing regimens

Official Title
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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)

Conditions
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Chronic Myeloid Leukemia (CML), Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL), Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)

Intervention / Treatment
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* Drug: Gleevec/Glivec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gleevec/Glivec<br> | Drug: Gleevec/Glivec<br> <br> * Other names: STI571;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 2 PK sample collection within 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of imatinib during the study period |  | study period of 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic myeloid leukemia, CML, Philadelphia chromosome positive, acute lymphoblastic leukemia, PhGlivec,, Gleevec,, hypereosinophilic syndrome,, HES,, chronic eosinophilic leukemia,, CEL,, myelodysplastic syndrome,, MDS,, myeloproliferative disease,, MPD+ ALL