Axicabtagene Ciloleucel Expanded Access Study

Therapuetic Areas:Oncology
Age Range:18 - Any
Contact:Medical Information

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

A Multicenter, Open-label, Expanded Access Study of Axicabtagene Ciloleucel for the Treatment of Subjects With Relapsed/Refractory Large B-cell Lymphoma.

A multicenter, open-label expanded access protocol for the treatment of subjects with
relapsed/refractory large B-cell lymphoma.

Inclusion Criteria:

1. Histologically confirmed large B-cell lymphoma, including the following types:

1. DLBCL, not otherwise specified

2. Primary mediastinal large B-cell lymphoma

3. High-grade B-cell lymphoma

4. DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL)

2. Relapsed or refractory disease, defined as one or more of the following:

1. No response to first-line therapy (primary refractory disease); subjects who are
intolerant to first-line therapy chemotherapy are excluded OR

2. No response or relapse to second or greater lines of therapy OR

3. Relapsed after ASCT

3. Subjects must have received adequate prior therapy including at a minimum:

1. anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20
negative, and

2. an anthracycline containing chemotherapy regimen;

4. No evidence, suspicion, and/or history of central nervous system (CNS) involvement of

5. Age 18 or older

6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1

7. Absolute neutrophil count ANC ≥1000/μL

8. Platelet count ≥75,000/μL

9. Absolute lymphocyte count ≥100/μL

10. Adequate renal, hepatic, pulmonary and cardiac function defined as:

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

2. Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤2.5 upper
limit of normal (ULN)

3. Total bilirubin ≤1.5 mg/dL, except in subjects with Gilbert's syndrome.

4. Cardiac ejection fraction ≥ 50% and no evidence of pericardial effusion within
180 days provide the subject did not receive an anthracycline based treatment or
experience a cardiac event or change in performance status

5. No clinically significant pleural effusion

6. Baseline oxygen saturation >92% on room air

11. Cohort 2 inclusion criteria: Subjects whose commercial manufacture of axicabtagene
ciloleucel did not meet commercial release specification(s)

Exclusion Criteria:

1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g.
cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3

2. History of allogeneic stem cell transplantation (SCT)

3. Prior CD19 targeted therapy

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

5. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides

6. Presence or suspicion of fungal, bacterial, viral, or other infection that is
uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple
urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if
responding to active treatment and after consultation with the Kite Pharma Medical

7. History of human immunodeficiency virus (HIV) infection or acute or chronic active
hepatitis B or hepatitis C infection. Subjects with a history of hepatitis infection
must have cleared their infection as determined by standard serological and genetic
testing per current Infectious Diseases Society of America (IDSA) guidelines

8. History or presence of primary CNS lymphoma and/or CNS disorder such as seizure
disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any
autoimmune disease with CNS involvement

9. Cohort 2 exclusion criteria: Any medical condition that, deemed by the investigator,
may interfere with assessment of safety or efficacy of study treatment
We found this trial at
Duarte, California 91010
Duarte, CA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Boston, MA
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Peter Reidell, MD
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
Chicago, IL
Click here to add this to my saved trials
Columbus, OH
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
Houston, TX
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-9183
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
Omaha, NE
Click here to add this to my saved trials
Rochester, Minnesota 55905
Rochester, MN
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
Seattle, WA
Click here to add this to my saved trials
Stanford, California 94305
Stanford, CA
Click here to add this to my saved trials
Tampa, FL
Click here to add this to my saved trials
Westwood, KS
Click here to add this to my saved trials