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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT03052933
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed relapsed or refractory PTCL or NK/T-cell lymphomas, excluding primary cutaneous T-cell lymphoma, and Sezary syndrome based on WHO classification,
* Age ≥ 19
* ECOG performance status ≤ 2
* at least one bi-dimensional measurable lesion
* Laboratory values
* Serum Cr \< 1.5 mg/dL or CrCl \> 50 mL/min
* Transaminase (AST/ALT) \< 2.5 x ULN (or \< 5 x ULN in the presence of lymphoma involvement of the liver)
* Bilirubin \< 1.5 x UNL ( or \< 3 x ULN in the presence of lymphoma involvement of the liver or Gilbert syndrome)
* PT (INR) ≤ 1.5 x ULN and aPTT ≤ 1.5 x ULN
* Lipase ≤ 1.5 x ULN
* Hematologic functions: absolute neutrophil count (ANC) ≥ 1,500/µL and platelet count ≥ 75,000/µL, hemoglobin ≥ 8 g/dL
* Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal for the institution
* Women of childbearing potential and men must agree to use adequate contraception when sexually active
* Written informed consent
Exclusion Criteria:
* B-cell NHL, or primary cutaneous T-cell lymphoma and Sezary syndrome
* Patients who had previous history of lymphoma involvement of the CNS.
* History of previous gemcitabine therapy
* Type I or II diabetes mellitus with HbA1c \> 8.5% at screening
* History of chronic hepatitis B; subjects positive for HBsAg will be excluded from this study. However, subjects with HBcAb will be eligible if they are negative for HBV DNA quantification
* History of chronic hepatitis C; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA quantification
* Known history of human immunodeficiency virus (HIV) infection
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
* Any other malignancies within the past 3 years except curatively treated basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, or papillary carcinoma of the thyroid
* Other serious illness or medical conditions
* Congestive heart failure \> NYHA class 2 (Appendix III)
* Unstable angina or new-onset angina within the last 3 months; Myocardial infarction within 6 months prior to study entry
* History of significant neurological or psychiatric disorders including dementia or seizure
* Uncontrolled hypertension despite optimal medical management (per investigator's opinion)
* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before start of study treatment
* Non-healing wound, ulcer, or bone fracture
* Active uncontrolled infection (viral, bacterial, or fungal infection)
* Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks of start of study medication
* Proteinuria estimated by urine protein/creatinine ratio \> 3.5 on a random urine sample
* Concurrent diagnosis of pheochromocytoma
* Other previous or concurrent treatments
* Ongoing immunosuppressive therapy
* Radiotherapy or immune-/chemotherapy less than 4 weeks before start of treatment
* Radioimmunotherapy or autologous transplant less than 3 months before start of treatment
* Myeloid growth factors within 14 days prior to treatment start
* Blood or platelet transfusion within 7 days prior to treatment start
* Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent
* History of having received an allogeneic bone marrow or organ transplant
* Major surgical procedure or significant trauma injury within 28 days before start of study medication, open biopsy within 7 days before start of study treatment
* Anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
* Use of CYP3A4 inhibitor or inducer
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Concomitant administration of any other experimental drugs under investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03052933
Study Brief:
Protocol Section:
NCT03052933