EUCTR2010-018418-53-NLActive, not recruitingNot Applicable
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
ovartis Pharma Service AG0 sites10 target enrollmentStarted: August 18, 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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