Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:January 2015
End Date:October 2034
Contact:Medical Information
Email:medinfo@kitepharma.com
Phone:1-844-454-5483(1-844-454-KITE)

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A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma

This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2
pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and
Cohort 4, and Cohort 5).

The primary objectives of this study are:

- Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens

- Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel

- Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier
interventions and tumor debulking therapy on the rate and severity of cytokine release
syndrome (CRS) and neurologic toxicity


Key Inclusion Criteria

1. Histologically confirmed:

- Diffuse Large B Cell Lymphoma (DLBCL)

- Primary Mediastinal Large B Cell Lymphoma (PMBCL)

- Transformation Follicular Lymphoma (TFL)

- High grade B-cell lymphoma (HGBCL)

2. Chemotherapy-refractory disease, defined as one of more of the following:

- No response to last line of therapy i. Progressive disease (PD) as best response
to most recent therapy regimen ii. Stable disease (SD) as best response to most
recent therapy with duration no longer than 6 month from last dose of therapy OR

- Refractory post-autologous stem cell transplant (ASCT) i. Disease progression or
relapsed less than or equal to 12 months of ASCT (must have biopsy proven
recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT,
the individual must have had no response to or relapsed after the last line of
therapy

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

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

- an anthracycline containing chemotherapy regimen

- for individuals with transformed FL must have received prior chemotherapy for
follicular lymphoma and subsequently have chemorefractory disease after
transformation to DLBCL

4. At least one measurable lesion per revised IWG Response Criteria

5. Age 18 or older

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

7. Absolute neutrophil count (ANC) ≥ 1000/uL

8. Absolute lymphocyte count ≥ 100/uL

9. Platelet count ≥ 75,000/uL

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

- Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min

- Serum alanine aminotransferase (ALT)/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 pleural effusion

- Baseline oxygen saturation >92% on room air

11. All individuals or legally appointed representatives/caregivers, must personally sign
and date the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
approved consent form before initiating any study specific procedures or activities.

Key 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

3. Prior CAR therapy or other genetically modified T cell therapy

4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
requiring IV antimicrobials for management. Simple urinary tract infection (UTI) and
uncomplicated bacterial pharyngitis are permitted if responding to active treatment

5. History of HIV infection or acute or chronic active hepatitis B or C infection.
Individuals with 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

6. Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases,
or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma,
cerebrospinal fluid malignant cells or brain metastases

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
24
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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Iowa City, IA
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Denver, Colorado 80218
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Detroit, Michigan 48202
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Duarte, California 91010
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Gilbert, Arizona 85234
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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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...
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Maywood, Illinois 60153
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Nashville, Tennessee 37203
Phone: 877-691-7274
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1211 Medical Center Drive
Nashville, Tennessee 37232
Phone: 800-811-8480
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Stanford, California 94305
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Tampa, Florida 33612
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Vancouver, British Columbia
Principal Investigator: Kevin Song, MD, FRCPC
Phone: 604-875-4111
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