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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT03348033
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic phase CML who lost response to the second line of treatment with tyrosine-kinase inhibitor (TKI) with indication for bone marrow transplantation.
* Accelerated phase patients who are candidates for bone marrow transplantation.
* Patient with CML in blast crisis.
* Patient aged between 2 and 59 years.
* patient should have recovered from the toxicity related to previous treatment of cytotoxic agents received within 4 weeks before starting treatment in this protocol, except for cytopenias resulting from persistent disease and alopecia, or non-haematological toxicities grades 1 and 2
Exclusion Criteria:
* Zubrod performance scale ≥ 2
* Renal impairment: Serum creatinine\> 2mg / dL for adults and\> 2mg / dL or\> 2 times the upper limit of normality for age (whichever is less) for children.
* Impaired hepatic function, defined as: total bilirubin\> 2 mg / dL and alanine aminotransferase (ALT) 2.5 times upper limit of normal for age (unless Gilbert's disease or abnormal liver function due to primary disease).
* Pulmonary symptoms with pulse oximetry \<92%.
* Congestive Heart Failure Classification New York Heart Association\> III
* Positive serological test for pregnancy within two weeks prior to enrollment in women of childbearing potential (non-fertile age defined as pre-menarche, post-menopausal over one year, or surgically sterilized).
* Positive serology for human immunodeficiency virus (HIV).
* Have undergone investigational therapies in four weeks prior to treatment begin under this protocol.
* Congestive heart failure \< 6 months prior to screening.
* Unstable angina \< 6 months before screening.
* Myocardial infarction \< 6 months prior to selection.
* Non-signing of the informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
59 Years
Study:
NCT03348033
Study Brief:
Protocol Section:
NCT03348033