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) | 
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.
			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.
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
	
									601 Elmwood Avenue
Rochester, New York 14642
	
			
					Rochester, New York 14642
Principal Investigator: Carla Casulo, MD
			
						
										Phone: 585-276-4404
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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
	
			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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									1100 Fairview Avenue North
Seattle, Washington 98109
	
			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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									450 Brookline Ave
Boston, Massachusetts 2215
	
			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
	
			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
	
			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
	
			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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								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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