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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT04071366
Eligibility Criteria:
Inclusion Criteria:
* Part 1: Eligible to receive any IEC therapy for any approved indication.
* Part 2: Eligible to receive Yescarta for relapsed or refractory large B-cell lymphoma or follicular lymphoma.
* Eastern Cooperative Oncology Group performance status 0 to 1.
* Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
* Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
* Evidence of active hepatitis B virus or hepatitis C virus infection.
* Known human immunodeficiency virus.
* Active acute or chronic graft-versus-host disease requiring systemic therapy.
* Concurrent use of chronic systemic steroids or immunosuppressant medications.
* Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy.
* Known history or prior diagnosis of immunologic or inflammatory/autoimmune disease affecting the central nervous system (CNS) and unrelated to their disease under study or previous treatment.
* Clinically significant or uncontrolled cardiac disease.
* Acute lymphoblastic leukemia participants with protocol-defined CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia.
* Diffuse large B-cell lymphoma participants must have no signs or symptoms of CNS disease or detectable evidence of CNS disease; participants who have been previously treated for CNS disease but have no evidence of disease at screening are eligible.
* Laboratory values at screening outside the protocol-defined ranges.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04071366
Study Brief:
Protocol Section:
NCT04071366