Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma

  • Interventional
  • Not Recruiting
  • NCT04002401
Eligibility Details Visit Clinicaltrials.gov

A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Key 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 renal, hepatic, pulmonary, and cardiac function

        Key Exclusion Criteria:

         - 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

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.

At a Glance

National Government IDNCT04002401

IRB#IRB19-0313

Lead SponsorGilead Sciences

Lead PhysicianSatyajit Kosuri

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting