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Clinical Trial 19070

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03153462

Phase: N/A
Prinicipal Investigator:

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Study Title

Multicenter, Open-Label, Expanded Access Study of Axicabtagene Ciloleucel or the Treatment of Subjects with Relapsed/Refractory Large B-Cell Lymphoma


The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after the participants receive a 3 day course of chemotherapy, is safe and effective in treating their disease.


The Primary Objective is to provide access of axicabtagene ciloleucel for subjects with relapsed/refractory aggressive NHL who are transplant ineligible until axicabtagene ciloleucel is commercially available in each respective participating country. Secondary Objectives are to describe the safety and efficacy of axicabtagene ciloleucel treatment.




Axicabtagene Ciloleucel (KTE-C19); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • Histologically confirmed aggressive B cell NHL, including the following types: a.) DLBCL; b.) primary mediastinal large B cell lymphoma; c). transformation of follicular lymphoma to DLBCL
  • Relapsed/refractory transplant ineligible disease
  • Must have received adequate prior therapy including at a minimum: a.) anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and b.) an anthracycline containing chemotherapy regimen
  • No evidence, suspicion and/or history of central nervous system (CNS) involvement of lymphoma
  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the participant is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the participant is planned for leukapheresis (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc.).
  • Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia)
  • Age 18 or older
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • Absolute lymphocyte count ≥100/μL
  • Adequate renal, hepatic, bone marrow, pulmonary and cardiac function
  • Females of childbearing potential must have a negative serum or urine pregnancy test

  • Exclusion Criteria

  • History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
  • History of Richter's transformation of CLL
  • ASCT within 6 weeks of planned axicabtagene ciloleucel infusion
  • History of allogeneic SCT
  • Prior CD19 targeted therapy with the exception of participants who received axicabtagene ciloleucel in this study and are eligible for re-treatment
  • Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
  • History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Medical Monitor.
  • Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
  • Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
  • Detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
  • History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  • Cardiac atrial or cardiac ventricular lymphoma involvement
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
  • Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression that occurs within 6 weeks of leukapheresis
  • Primary immunodeficiency
  • History of autoimmune disease (e.g., Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
  • History of deep vein thrombosis or pulmonary embolism within 6 months of enrollment
  • Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
  • History of severe immediate hypersensitivity reaction to any of the agents used in this study
  • Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen
  • Pregnant or breastfeeding
  • Males or females not willing to practice birth control from the time of consent through 6 months after the completion of axicabtagene ciloleucel

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