Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kite, A Gilead Company
Following at least 24 months of assessments after axicabtagene ciloleucel infusion, participants will be asked to rollover to a separate long-term follow-up study (Study KT-US-982-5968). Participants will complete the remainder of the 15-year follow-up assessments in the KT-US-982-5968 study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed large B-cell lymphoma
Chemotherapy-refractory disease, defined as one or more of the following:
* No response to first-line therapy (primary refractory disease)
* No response to second or greater lines of therapy OR
* Refractory after autologous stem cell transplant (ASCT)
At least 1 measureable lesion according to the Lugano Classification (Cheson 2014).
Individuals must have received adequate prior therapy, including at a minimum:
* Anti-CD20 monoclonal antibody
* An anthracycline-containing chemotherapy regimen
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate renal, hepatic, pulmonary, and cardiac function
You may not be if
Known CD19 negative or CD20 negative tumor
History of Richter's transformation of Chronic Lymphocytic Leukemia (CLL)
Prior CAR therapy or other genetically modified T-cell therapy
Prior organ transplantation including prior allogeneic stem cell transplant (SCT)
Prior CD19 targeted therapy
Clinically significant infection or cardiopulmonary disease
Presence of any in-dwelling lines or drains (dedicated central venous access catheters allowed)
History or presence of central nervous system (CNS) lymphoma or nonmalignant CNS disorder or cerebrospinal fluid (CSF) malignant cells or brain metastases
History of autoimmune disease
History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 6 months
Clareo Health | Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma
