A Study to Evaluate the Safety and Effectiveness of Axicabtagene Ciloleucel in Combination eith Either Rituximab or Lenalidomide in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)

Overview

About this study

The primary objective of this study is to estimate the safety and effectiveness of axicabtagene ciloleucel in combination with either rituximab or lenalidomide, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • 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 bone marrow, renal, hepatic, pulmonary, and cardiac function. 
  • Individuals must be able to comply with the requirements of REVLIMID Risk Evaluation and Mitigation Strategy (REMS)® .

Exclusion Criteria: 

  • Known CD19 negative or CD20 negative tumor. 
  • History of Richter's transformation of Chronic Lymphocytic Leukemia (CLL).
  • Prior lenalidomide or other immunomodulatory imide drug (IMiD) treatment.
  • 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 year.
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jose Villasboas Bisneto, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jose Villasboas Bisneto, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Jose Villasboas Bisneto, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20475819

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