Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:December 14, 2017
End Date:January 15, 2035
Contact:Medical Information
Email:medinfo@kitepharma.com
Phone:1-844-454-5483(1-844-454-KITE)

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A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma

The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the
clinical outcome compared with standard of care second-line therapy in patients with
relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of
axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory
DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and
anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene
ciloleucel or standard of care second-line therapy.

Standard of care will consist of a protocol-defined, platinum-based salvage combination
chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in
those who respond to salvage chemotherapy.

Key Inclusion Criteria:

1. Histologically proven DLBCL, including transformation from follicular lymphoma

2. Relapsed or refractory disease after first-line chemoimmunotherapy

- Refractory disease is defined as no complete remission to first-line therapy;
individuals who are intolerant to first-line therapy are excluded.

- Progressive disease (PD) as best response to first-line therapy

- Stable disease (SD) as best response after at least 4 cycles of first-line
therapy

- Partial response (PR) as best response after at least 6 cycles and
biopsy-proven residual disease or disease progression ≤ 12 months from
initiation of therapy

- Relapsed disease defined as complete remission to first-line therapy followed by
biopsy-proven relapse ≤ 12 months of initiating first-line therapy

3. Individuals must have received adequate first-line therapy including at a minimum:

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

- An anthracycline containing chemotherapy regimen

4. No known history or suspicion of central nervous system involvement by lymphoma

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

6. Adequate bone marrow function as evidenced by:

- Absolute neutrophil count (ANC) ≥ 1000/uL

- Platelet ≥ 75,000/uL

- Absolute lymphocyte count ≥ 100/uL

7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:

- Creatinine clearance (Cockcroft Gault) ≥ 60 mL/min

- Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper
limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dl

- Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as
determined by an Echocardiogram (ECHO), and no clinically significant
Electrocardiogram (ECG) findings

- No clinically significant pleural effusion

- Baseline oxygen saturation > 92% on room air

Key Exclusion Criteria:

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

2. Received more than one line of therapy for DLBCL

3. History of autologous or allogeneic stem cell transplant

4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
requiring intravenous antimicrobials for management.

5. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B
(HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive
history of treated hepatitis B or hepatitis C, the viral load must be undetectable per
quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.

6. Individuals with detectable cerebrospinal fluid malignant cells or known brain
metastases, or with a history of cerebrospinal fluid malignant cells or brain
metastases.

7. History or presence of non-malignant central nervous system (CNS) disorder such as
seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease,
or any autoimmune disease with CNS involvement

8. Presence of any indwelling line or drain. Dedicated central venous access catheter
such as a Port-a-Cath or Hickman catheter are permitted.

9. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,
New York Heart Association Class II or greater congestive heart failure, or other
clinically significant cardiac diseases within 12 months of enrollment

10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of
enrollment

11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic
disease modifying agents within the last 2 years

12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
29
sites
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Reem Karmali, MD
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Brian Hill, MD, PhD
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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4100 John R
Detroit, Michigan 48201
800-527-6266
Principal Investigator: Abhinav Deol, MD
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Patrick Reagan, MD
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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Baltimore, Maryland 21201
Principal Investigator: Aaron Rapoport, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Caron Jacobson, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Craig Portell, MD
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Peter Riedell, MD
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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460 West 10th Avenue
Columbus, Ohio 43210
Principal Investigator: Samantha Jaglowski, MD
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Gilbert, Arizona 85234
Principal Investigator: Javier Munoz, MD
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Gilbert, AZ
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Graz,
Principal Investigator: Hildegard Greinix, MD
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Principal Investigator: Lori Leslie, MD
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Jason Westin, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Iowa City, Iowa 52242
Principal Investigator: Umar Farooq, MD
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Kansas City, Kansas 66160
Principal Investigator: Joseph McGuirk, DO
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Miami, Florida 33136
Principal Investigator: Lazaros Lekakis, MD
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Ian Flinn, MD
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, Tennessee 37232
Principal Investigator: Olalekan Oluwole, MD
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Keren Osman, MD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Miguel-Angel Perales, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Kathleen Dorritie, MD
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Rochester, Minnesota 55905
Principal Investigator: Patrick Johnston, MD, PhD
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Armin Ghobadi, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84112
Principal Investigator: Catherine Lee, MD
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San Diego, California 92093
Principal Investigator: Dimitrios Tzachanis, MD, PhD
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Santa Monica, California 90404
Principal Investigator: Sven de Vos, MD
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Seattle, Washington 98104
Principal Investigator: John Pagel, MD, PhD
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Stanford, California 94305
Principal Investigator: David Miklos, MD
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Tampa, Florida 33612
Principal Investigator: Fred Locke, MD
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