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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT01273766
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a pathology confirmed diagnosis of one of the following: myelodysplastic syndrome (MDS); acute leukemia; multiple myeloma; myelofibrosis; lymphoma; chronic anemia; sickle cell anemia
* Iron score \>= 2
* Absolute Neutrophil Count (ANC) \>= 1,000
* Platelets \>= 50,000
* Albumin \>= 2 g/dL
* Alkaline phosphatase =\< 5X Upper Limit of Normal (ULN)
* Total bilirubin =\< 1.5
* Creatinine =\< 2X age-appropriate Upper Limit of Normal (ULN) OR creatinine clearance \>= 40 ml/min
* Serum Glutamic Oxaloacetic Transaminase (SGOT) \[AST\] and Serum Glutamic Pyruvic Transaminase (SGPT) \[ALT\] =\< 5X Upper Limit of Normal (ULN)
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with active disease undergoing chemotherapy treatment
* Patient who have been treated with rituximab or immunomodulating drugs =\< 1 month prior to enrollment
* HIV-positive patients
* Hepatitis-C positive patients
* Women who are pregnant or breastfeeding
* Patients on hemodialysis/patients with renal failure
* Patients with sepsis or acute illness
* Known hypersensitivity to deferasirox
* Patients with moderate or severe hearing loss as defined by audiogram
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01273766
Study Brief:
Protocol Section:
NCT01273766