Non Hodgkin Lymphoma Clinical Trial

Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma

Summary

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, Cohort 5 and Cohort 6).

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 on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities

Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria

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)

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

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 individual with transformed FL must have chemorefractory disease after transformation to DLBCL.
At least one measurable lesion per revised IWG Response Criteria
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Absolute neutrophil count (ANC) ≥ 1000/uL
Absolute lymphocyte count ≥ 100/uL
Platelet count ≥ 75,000/uL

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
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.
Relapsed or refractory large B-cell lymphoma including DLBCL, PMBCL, TFL, and HGBCL after two systemic lines of therapy

Key Exclusion Criteria

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
History of allogeneic stem cell transplantation
Prior CAR therapy or other genetically modified T cell therapy
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
History of human immunodeficiency virus (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
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
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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

307

Study ID:

NCT02348216

Recruitment Status:

Active, not recruiting

Sponsor:

Kite, A Gilead Company

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There are 35 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
City of Hope
Duarte California, 91010, United States
University of California San Diego (UCSD)
La Jolla California, 92093, United States
Stanford University
Palo Alto California, 94305, United States
University of California Los Angeles (UCLA)
Santa Monica California, 90404, United States
Sarah Cannon - Denver
Denver Colorado, 80218, United States
University of Miami
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Center
Detroit Michigan, 48201, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
University of Nebraska
Omaha Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Montefiore Medical Center
Bronx New York, 10467, United States
University of Rochester
Rochester New York, 14642, United States
Cleveland Clinic - Taussig Cancer Institute
Cleveland Ohio, 44195, United States
Sarah Cannon - Tennesee
Nashville Tennessee, 37203, United States
Vanderbilt University
Nashville Tennessee, 37232, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Sarah Cannon-Methodist Healthcare System - San Antonio
San Antonio Texas, 78229, United States
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
Princess Margaret
Toronto Ontario, M5G 2, Canada
Hopital Saint Louis
Paris , 75475, France
Hopital Haut-Leveque
Pessac , 44035, France
CHU de Rennes
Rennes , 35033, France
Universitätsklinik Dresden
Dresden , 01307, Germany
University Hospital of Essen
Essen , 45147, Germany
Universitaetsklinikum Wuerzburg
Würzburg , 97080, Germany
Tel Aviv Souraski Medical Center
Tel Aviv , 64239, Israel
Academisch Medisch Centrum
Amsterdam , , Netherlands
University Medical Center Groningen
Groningen , 9700 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands
University Medical Center Utrecht
Utrecht , 3584 , Netherlands

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

307

Study ID:

NCT02348216

Recruitment Status:

Active, not recruiting

Sponsor:


Kite, A Gilead Company

How clear is this clinincal trial information?

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