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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT02259556
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
* Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.
* Karnofsky or Lansky score greater than 60%.
* Expected survival\>12 weeks.
* Creatinine\<2.5mg/dl.
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 fold normal.
* Bilirubin\<2.5mg/dl.
* Pulse oximetry of \>90% on room air.
* Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.
* Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
* Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
Exclusion Criteria:
* Active infection such as hepatitis B or C.
* Receive anti-CD30 antibody-based therapy within recent 6 weeks.
* Current use of systemic corticosteroids.
* Pregnant or lactating.
* Confirmed tumor in pulmonary and archenteric tissues.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT02259556
Study Brief:
Protocol Section:
NCT02259556