STATUS Study Complete

Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma (ZUMA-12)

Kite Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Study Complete

GILEAD STUDY ID

KTE-C19-112

Kite Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

December 04, 2024

Clinicaltrials.gov ID

NCT03761056

EudraCT ID

2019-002291-13

STUDY DOCUMENTS

View study documents

OVERVIEW

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) (ZUMA-12)

PROTOCOL SUMMARY

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma. After the end of KTE-C19-112 (ZUMA-12), participants who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

B-cell Lymphoma

Gender

N/A

Date

January 2019 - October 2023

Study Type

Interventional

Study Phase

Phase 2

Product

Axicabtagene Ciloleucel, Fludarabine, Cyclophosphamide

Eligibility information

Inclusion criteria

Histologically confirmed large B-cell lymphoma
High-grade large B-cell lymphoma
Individuals must have a positive interim positron emission tomography (PET) (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 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 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.