A non-randomized, open-label study to characterize the pharmacokinetics 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 (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
MedDRA version: 12.1Level: LLTClassification code 10009015Term: Chronic myeloid leukemia
MedDRA version: 12.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemia

Registration Number: EUCTR2010-018418-53-NL

Lead Sponsor: ovartis Pharma Service AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

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 (Table7-2)
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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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) (Post-text supplement 1)
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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary<br>To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to<br>less than 4 years via appropriate integrated PBPK and pop PK approaches<br>;Secondary Objective: Secondary<br>To assess the safety and tolerability of imatinib in pediatric patients age 1 to<br>less than 4 during the study period.;Primary end point(s): • Pharmacokinetic data<br>• CL/F (apparent clearance)<br>• V/F (apparent volume of distribution)<br>• Tmax<br>• PBPK parameters (plasma protein binding and a-1 acid glycoprotein<br>concentration)<br>• Cmax<br>• AUC<br>

Secondary Outcome Measures

Name	Time	Method

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