Axicabtagene Ciloleucel Expanded Access Study

Description

This is a multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory transplant ineligible aggressive NHL.

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Biological: Axicabtagene Ciloleucel

Study ID

Kite Pharma, Inc. -- KTE-C19-109

Status

Available

Trial ID

NCT03153462

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Kite Pharma, Inc.

Inclusion Criteria

    1. Relapsed/refractory transplant ineligible 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 to second or greater lines of therapy OR 3. Relapsed after ASCT OR 4. Relapsed transplant ineligible disease 2. 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 3. Age 18 or older 4. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 5. ANC ?1000/?L 6. Platelet count ?75,000/?L 7. Absolute lymphocyte count ?100/?L 8. Adequate renal, hepatic, pulmonary and cardiac function defined as: 1. Creatinine clearance (as estimated by Cockcroft Gault) ? 60 mL/min 2. Serum ALT/AST ?2.5 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 9. 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

Exclusion Criteria

    1. History of allogeneic stem cell transplantation 2. Prior CD19 targeted therapy with the exception of subjects who received axicabtagene ciloleucel in this study and are eligible for re-treatment 3. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy 4. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides 5. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Medical Monitor. 6. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing. 7. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases 8. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (18)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Michael Rocchio None michaelj_rocchio@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Michael Rocchio None michaelj_rocchio@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Michael Rocchio None michaelj_rocchio@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Michael Rocchio None michaelj_rocchio@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Michael Rocchio None michaelj_rocchio@dfci.harvard.edu
University of Chicago - Chicago, Illinois 848.0 miles Linda Schroeder None lschroed@medicine.bsd.uchicago.edu
University of Chicago - Chicago, Illinois 848.0 miles Linda Schroeder None lschroed@medicine.bsd.uchicago.edu
University of Chicago - Chicago, Illinois 848.0 miles Linda Schroeder None lschroed@medicine.bsd.uchicago.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Kristin Arends None arends.kristen@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Kristin Arends None arends.kristen@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Kristin Arends None arends.kristen@mayo.edu
H Lee Moffitt Cancer Center - Tampa, Florida 1,178.7 miles Matthew Scott None matthew.scott@moffitt.org
The University of Texas MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Sherry Adkins None sadkins@mdanderson.org
The University of Texas MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Sherry Adkins None sadkins@mdanderson.org
The University of Texas MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Sherry Adkins None sadkins@mdanderson.org
The University of Texas MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Sherry Adkins None sadkins@mdanderson.org
The University of Texas MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Sherry Adkins None sadkins@mdanderson.org
Stanford Cancer Institute - Stanford, California 2,694.5 miles Julianna Craig None jkcraig@stanford.edu

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