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Clinical Trial 19721

Cancer Type: Malignant Hematology
Interventions:Axicabtagene Ciloleucel (KTE-C19); cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Julio Chavez

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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)

Summary

Objective

The primary objective of the study is to estimate the efficacy of axicabtagene ciloleucel, as measured by complete response (CR) rate, in subjects with high-risk large B-cell lymphoma. Secondary objectives will include assessing the safety of axicabtagene ciloleucel and additional efficacy endpoints.

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.
  • 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

  • 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
  • Other protocol defined Inclusion/Exclusion criteria may apply.