Clinical trial · Interventional
Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to \<4 years of age to help develop dosing regimens
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
| Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN) | — | UNRESOLVED | — |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec/Glivec | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gleevec/Glivec
- interventionNames
- Drug: Gleevec/Glivec
Primary outcomes (1)
- 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)
- timeFrame
- 2 PK sample collection within 21 days
Secondary outcomes (1)
- measure
- safety and tolerability of imatinib during the study period
- timeFrame
- study period of 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 3 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available