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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT02545361
Eligibility Criteria:
Inclusion Criteria:
* Subjects diagnosed with recurrent malignant lymphoma, which express B7 and FasR and have either failed to respond to standard therapy, relapsed and for whom no standard therapy is available.
* Measurable disease as measured by "Lugano" Classification.
* A measurable node must have a longest diameter (LDi) greater than 1.5 cm. Measurable extranodal disease (eg, hepatic nodules) may be included in the six representative, measured lesions. A measurable extranodal lesion should have an LDi greater than 1.0 cm
* Biopsy of tumor stains positive to cluster of differentiation 95 (CD95) and to Cluster of Differentiation 80 (CD80) or Cluster of Differentiation 86 (CD86) or both within the last 6 months.
* If greater than 6 months , a fine-needle aspiration (FNA) should be performed
* Men and Women age \> 18.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3.
* Estimated life expectancy of at least 2 months.
* Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase, aspartate aminotransferase ≤2× ULN).
* Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥30 ml/min/1.73m2 as measured by Cockcroft -Gault / CKD (Chronic Kidney Disease)/EPI (Epidemiology Collaboration) formulas.
* Platelet count ≥ 50,000 and an absolute neutrophil count (ANC) ≥ 1500 /mm3.
* Women of child bearing potential practicing an acceptable method of birth control.
* Understanding of study procedures and willingness to comply for the entire length of the study and to give written informed consent.
Exclusion Criteria:
* Other standard anti-neoplastic therapies are available.
* Known Central Nervous System (CNS) lymphoma.
* Chronic lymphocytic leukemia and autoimmunity leukemia.
* Known hypersensitivity to the study drug or to any of its components.
* Chronic heat failure (CHF) New-York heart association (NYHA) = Class IV.
* Known Chronic Obstructive Pulmonary Disease (COPD) \> Stage 3 (Forced Expiratory Volume -(FEV1)\<50%, FEV1/Forced Vital Capacity (FVC)\<70%).
* Chronic kidney disease (CKD) \>Stage 4 (subjects with known Filtration rate (FR)\<30 milliliter (mL)/min/1.73m2).
* Cirrhosis (Child-Pugh Class C score).
* Known hypersensitivity to drug components.
* Prior chemotherapy within 3 weeks, nitrosureas within 6 weeks, therapeutic anticancer antibodies within 3 weeks, radio or toxin immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 28 days of first dose of the study drug.
* American Society for Cytotechnology (ASCT) and prior allogeneic stem cell transplantation (SCT)\< 12 weeks prior to first dose of the study drug.
* Myelosuppressive treatment within 2-3 weeks of entering this study. Prednisone allowed.
* Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study.
* Positive test for acquired immune deficiency syndrome (AIDS).
* Any positive test for hepatitis B or hepatitis C virus (HBV or HCV) indicating acute or chronic infection (HBsAg, HBcAb total and anti-HCV Abs).
* Presence of uncontrolled infection.
* Evidence of active bleeding or bleeding susceptibility or medically significant hemorrhage within prior 30 days.
* Coumadin therapy.
* Pregnant or lactating.
* Treatment with other investigational drugs within 14 days of start of this study.
* Prisoners or subjects who are involuntarily incarcerated.
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02545361
Study Brief:
Protocol Section:
NCT02545361