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)
1 Year
3 Years
Both
Chronic Myeloid Leukemia (CML), Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL), Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
Trial Information
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)
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/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
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)
Outcome Time Frame:
2 PK sample collection within 21 days
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSTI571A2110
NCT ID:
NCT01066468
Start Date:
October 2010
Completion Date:
Related Keywords:
- Chronic Myeloid Leukemia (CML)
- Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
- Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
- 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
- Hematologic Diseases
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
- Myelodysplastic-Myeloproliferative Diseases
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