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

Chronic Myeloid Leukemia (CML) Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01066468
• Other study ID #: CSTI571A2110
• Secondary ID: 2010-018418-53
• Status: Terminated
• Phase: Phase 1
• First received: February 9, 2010
• Last updated: March 12, 2012
• Start date: October 2010

Study information

• Verified date: March 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHungary: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Medicines Evaluation Board (MEB)Russia: Ministry of Health of the Russian FederationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4 years of age to help develop dosing regimens

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abnormal Karyotype
• Chronic Myeloid Leukemia (CML)
• Hematologic Diseases
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Myelodysplastic-Myeloproliferative Diseases
• Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
• Philadelphia Chromosome
• Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Gleevec/Glivec

Locations

Country	Name	City	State
Russian Federation	Novartis Investigative Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a-1 acid glycoprotein concentration)		2 PK sample collection within 21 days	No
Secondary	safety and tolerability of imatinib during the study period		study period of 21 days	Yes