Study Details

PROTOCOL SUMMARY

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

Medical Condition

Relapsed/Refractory Diffuse Large B Cell Lymphoma, Relapsed/Refractory Primary Mediastinal B Cell Lymphoma, Relapsed/Refractory Transformed Follicular Lymphoma, Relapsed/Refractory High-Grade B-Cell Lymphoma

Gender

N/A

Date

Study Type

EXPANDED_ACCESS

Study Phase

Product

Axicabtagene Ciloleucel

Eligibility Information

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 lymphoma
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 years
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 Monitor
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

Locations

Locations (15)

City of Hope

Duarte, California, United States, 91010

Stanford Cancer Institute

Stanford, California, United States, 94305

University of Miami Hospital and Clinics

Miami, Florida, United States, 33136

H. Lee Moffitt Cancer and Research Institute

Tampa, Florida, United States, 33612

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

The University of Kansas Hospital Investigational Drug Services

Westwood, Kansas, United States, 66205

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Mayo Clinic

Rochester, Minnesota, United States, 55905

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Cleveland Clinic

Cleveland, Ohio, United States, 44195

James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

University of Washington Medical Center

Seattle, Washington, United States, 98109

Axicabtagene Ciloleucel Expanded Access Study (ZUMA-9)

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