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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:January 29, 2019
End Date:January 2035
Contact:Medical Information
Email:medinfo@kitepharma.com
Phone:1-844-454-5483(1-844-454-KITE)

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
4
sites
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Duarte, California 91010
?
mi
from
Duarte, CA
Click here to add this to my saved trials