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Closed (no longer recruiting)Last updated: 1 February 2024

ZUMA-12: This phase III trial is trying to determine how effective an immunotherapy (axicabtagene ciloleucel) is in treating high-risk Large B-Cell LymphomaA 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

Clinical summary

Summary

Eligible participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, axicabtagene ciloleucel.

Conditions

This trial is treating patients with B-Cell Lymphoma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

ZUMA-12

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Kite, A Gilead Company

Scientific 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

Eligibility

Inclusion

  • 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 central nervous system (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) and aspartate aminotransferase (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 echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
  • No clinically significant pleural effusion
  • Baseline oxygen saturation > 92% on room air

Exclusion

  • 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 human immunodeficiency virus (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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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