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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066468
Recruitment Status : Terminated
First Posted : February 10, 2010
Last Update Posted : March 13, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN) Drug: Gleevec/Glivec Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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)
Study Start Date : October 2010
Actual Primary Completion Date : May 2011

Arm Intervention/treatment
Experimental: Gleevec/Glivec Drug: Gleevec/Glivec
Other Name: STI571

Primary Outcome Measures :
  1. 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) [ Time Frame: 2 PK sample collection within 21 days ]

Secondary Outcome Measures :
  1. safety and tolerability of imatinib during the study period [ Time Frame: study period of 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066468

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Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 117997
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01066468    
Other Study ID Numbers: CSTI571A2110
2010-018418-53 ( EudraCT Number )
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic myeloid leukemia
Philadelphia chromosome positive
acute lymphoblastic leukemia
hypereosinophilic syndrome,
chronic eosinophilic leukemia,
myelodysplastic syndrome,
myeloproliferative disease,
Additional relevant MeSH terms:
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Imatinib Mesylate
Leukemia, Myeloid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Philadelphia Chromosome
Pathologic Processes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Translocation, Genetic
Chromosome Aberrations
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action