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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT03598959
Eligibility Criteria:
Inclusion Criteria:
* 1\. Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
2\. Adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dL.
3\. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal.
4.. Adequate cardiac function with left ventricular ejection fraction \>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
5\. Performance status 0-1. 6. Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Exclusion Criteria:
-1. Patients relapsed after allogeneic stem cell transplant 2. Patients with active hepatitis B or C(HBV DNA \>/=10,000 copies/mL). 3. Active infection requiring parenteral antibiotics 4. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts 5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
6\. Patients with a cQT longer than 500 ms
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT03598959
Study Brief:
Protocol Section:
NCT03598959