Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma

  • Interventional
  • Not Recruiting
  • NCT03761056
Eligibility Details Visit Clinicaltrials.gov

A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12)

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk 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

         - High-grade large B-cell lymphoma

         - Individuals must have a positive interim positron emission tomography (PET) per Cheson, 2014 (Deauville PET score of 4 or 5) after 2 cycles (PET2+) of chemoimmunotherapy

         - No evidence, suspicion and/or history of CNS involvement of lymphoma

         - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

         - Absolute neutrophil count ≥ 1000/μL

         - Platelet count ≥ 75,000/μL

         - Absolute lymphocyte count ≥ 100/μL

         - Adequate renal, hepatic, pulmonary, and cardiac function defined as:

             - Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min

             - Serum alanine aminotransferase (ALT/AST) ≤ 2.5 upper limit of normal (ULN)

             - Total bilirubin ≤1.5 mg/dL, except in individuals with Gilbert's syndrome

         - Cardiac ejection fraction ≥ 50% , no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings

         - No clinically significant pleural effusion

         - Baseline oxygen saturation > 92% on room air

        Key Exclusion Criteria:

         - History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years

         - History of Richter's transformation of chronic lymphocytic leukemia or primary mediastinal B-cell lymphoma

         - History of autologous or allogeneic stem cell transplant

         - Prior CD19-targeted therapy

         - Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy

         - Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management

         - History of HIV infection or acute or chronic active hepatitis B or C infection

         - Presence of any indwelling line or drain dedicated central venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted

         - Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or active CNS lymphoma

         - History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

         - History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment

         - History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years

         - History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment

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

At a Glance

National Government IDNCT03761056

IRB#IRB18-1453

Lead SponsorKite, A Gilead Company

Lead PhysicianPeter Riedell

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting