A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:June 20, 2017
End Date:March 2035
Contact:Medical Information
Email:medinfo@kitepharma.com
Phone:1-844-454-5483(1-844-454-KITE)

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A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)

This study will enroll approximately 160 adult subjects who have relapsed or refractory (r/r)
iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease
responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is
made from the subjects own white blood cells which are genetically modified and grown to
fight cancer. An objective response rate of 70% is targeted.

This study will enroll approximately 160 adult subjects who have relapsed or refractory (r/r)
iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease
responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is
made from the subjects own white blood cells which are genetically modified and grown to
fight cancer. An objective response rate of 70% is targeted.

All enrolled subjects will be screened for eligibility then will undergo leukapheresis to
collect white blood cells for manufacturing. In preparation for the infusion with
axicabtagene ciloleucel, subjects will undergo conditioning chemotherapy with
cyclophosphamide and fludarabine for 3 days to help the study treatment be effective. After
the product is manufactured and conditioning chemotherapy period is complete, subjects will
be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7
days. Subjects will be followed by their study doctor for continued monitoring of the safety
and effectiveness of the study treatment for approximately 3 months after receiving treatment
and then will be followed for safety for up to an additional 15 years.

Key Inclusion Criteria:

1. Individual has [follicular lymphoma or marginal zone lymphoma that has progressed
after at least 2 lines of treatment with combination chemoimmunotherapy] (e.g.
R-bendamustine, R-CHOP).

2. Individual has [measurable disease].

3. Individual has no known presence or history of central nervous system (CNS)
involvement by lymphoma.

4. If individual is on conventional systemic therapy or systemic inhibitory/stimulatory
immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or
5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to
planned leukapheresis.

5. Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and
adequate renal, hepatic, pulmonary, and cardiac function

6. Individual is not pregnant or breastfeeding (female individuals only) and is willing
to use birth control from the time of consent through 6 months following chimeric
antigen receptor (CAR) T cell infusion (both male and female individuals).

Key Exclusion Criteria:

1. Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)

2. Small lymphocytic lymphoma

3. Histological Grade 3b FL

4. Individual will have undergone autologous transplant within 6 weeks of planned
leukapheresis or has undergone allogeneic transplant.

5. Individual has evidence of involvement of the heart by lymphoma or requirement for
urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect,
tumor lysis syndrome, etc.)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
18
sites
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: David Maloney, MD, PhD
Phone: 206-606-4668
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Sven de Vos, MD, PhD
Phone: 310-267-2756
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Olalekan Oluwole, MD
Phone: 615-343-7190
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Caron Jacobson, MD
Phone: 617-582-8713
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Columbus, Ohio 43210
Principal Investigator: Basem William, MD
Phone: 614-688-9796
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Gilbert, Arizona 85234
Principal Investigator: Javier Munoz, MD
Phone: 480-256-3421
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Hackensack, New Jersey 07601
Principal Investigator: Lori Leslie, MD
Phone: 551-996-5168
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Houston, Texas 77030
Principal Investigator: Sattva Neelapu, MD
Phone: 713-563-4167
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Lille, 59037
Principal Investigator: Ibrahim Yakoub-Agha, MD
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Kevin Kelly, MD
Phone: 323-865-3828
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Miami, Florida 33136
Principal Investigator: Joseph Rosenblatt, MD
Phone: 305-243-7648
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Ian Flinn, MD, PhD
Phone: 615-339-4214
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Ran Reshef, MD
Phone: 212-342-3849
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Philadelphia, Pennsylvania 19111
Principal Investigator: Henry Fung, MD
Phone: 215-214-3125
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Alison Sehgal, MD
Phone: 412-623-6037
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601 Elmwood Avenue
Rochester, New York 14642
Principal Investigator: Carla Casulo, MD
Phone: 585-276-4404
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Tampa, Florida 33612
Principal Investigator: Julio Chavez, MD
Phone: 813-745-7227
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Washington, District of Columbia 20007
Principal Investigator: Pashna Munshi, MD
Phone: 202-444-1212
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