Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic M… (NCT01273766) | Clinical Trial Compass
CompletedPhase 2
Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
United States16 participantsStarted 2011-01
Plain-language summary
RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions.
PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/pati…
What they're measuring
1
Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)