Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT01066468
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT01066468
Study Brief:
Protocol Section:
NCT01066468