Chronic Myeloid Leukemia (CML), Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN), Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Conditions
Keywords
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
Brief summary
This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to \<4 years of age to help develop dosing regimens
Interventions
DRUGGleevec/Glivec
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
No
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 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
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) 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 guardians, in the opinion of the Investigator, were unlikely to comply with the protocol or safety monitoring requirements Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| safety and tolerability of imatinib during the study period | study period of 21 days |
Countries
Russia
Outcome results
None listed