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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00792467
Eligibility Criteria:
Inclusion Criteria:
* Written Informed Consent;
* Age ≥18 years;
* Histologically confirmed diagnosis of Hodgkin's lymphoma;
* Subjects who have failed second-line or subsequent-line salvage chemo- radiotherapy regimens for whom no other treatment options of proven efficacy can be given;
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements;
* ANC ≥1500/µL; Platelet count ≥75000/µL;
* Hemoglobin ≥9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level);
* Total bilirubin ≤1.6 mg/dL; AST or ALT ≤2.5 times the upper limit of normal;
* Serum creatinine ≤2.0 mg/dL or creatinine clearance \>50 mL/min;
* Serum Potassium and Magnesium within normal limits;
* Subjects with at least one bi-dimensional lesion measurable by CT-scan or MRI, according to the Revised Response Criteria for Malignant Lymphoma of the International Working Group (J Clin Oncol, 25:579-586, 2007);
* ECOG performance status of 0 or 1;
* Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential;
* Life expectancy of \>3 months;
* Subjects receiving intravenous Mechlorethamine (6 mg/sqm) as single agent at least 4 weeks before study entry;
* Willingness and capability to comply with the requirements of the study.
Exclusion Criteria:
* Active bacterial or mycotic infection requiring antimicrobial treatment
* Pregnancy or lactation
* Anticancer chemotherapy or radiotherapy during the study or within 4 weeks of study entry.
* A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval \> 450 ms, according to Bazett's correction formula - see appendix I for the formula)
* Use of concomitant medications that prolong the QT/QTc interval (see appendix H for full list)
* Clinically significant cardiovascular disease including:
* Uncontrolled hypertension, myocardial infarction, unstable angina
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of any cardiac arrhythmia requiring medication (irrespective of its severity)
* A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* Positive blood test for HIV, HBV and HCV
* Identification of viral DNA by quantitative PCR for EBV and JC virus.
* History of other diseases, metabolic dysfunctions, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00792467
Study Brief:
Protocol Section:
NCT00792467