CD19 CART Long Term Follow Up (LTFU) Study
| Status: | Recruiting | 
|---|---|
| Healthy: | No | 
| Age Range: | Any | 
| Updated: | 3/31/2019 | 
| Start Date: | November 2, 2015 | 
| End Date: | May 17, 2035 | 
| Contact: | Novartis Pharmaceuticals | 
| Phone: | 1-888-669-6682 | 
Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 Directed CAR T-Cell Therapy
Per Health Authorities guidelines for gene therapy medicinal products that utilize
integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of
treated patients is required. The purpose of this study is to monitor all patients exposed to
CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019)
infusion to assess the risk of delayed adverse events (AEs), monitor for replication
competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.
			integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of
treated patients is required. The purpose of this study is to monitor all patients exposed to
CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019)
infusion to assess the risk of delayed adverse events (AEs), monitor for replication
competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.
Patients are enrolled following completion or early discontinuation from a Novartis sponsored
or supported study of CD19 directed CAR T-Cell treatment and will be followed for 15 years
post treatment from the last CD19 directed CAR T-Cell treatment. Patients will be monitored
for safety and efficacy within the primary treatment protocols for the protocol defined
duration. While every effort will be made to keep patients in follow-up within the respective
treatment protocol itself, patients can drop off treatment protocols at any time. Patients
discontinuing from the primary treatment protocols for any reason will be enrolled in this
long term follow up (LTFU). This will allow collecting data on long term safety and efficacy
(as applicable) as mandated by the health authorities of all patients treated with CD19 CART
therapy within the concept of a single protocol.
Collection of such long term effects of CD19 CART cell therapy will help to further define
the risk-benefit profile of CD19 CART.
or supported study of CD19 directed CAR T-Cell treatment and will be followed for 15 years
post treatment from the last CD19 directed CAR T-Cell treatment. Patients will be monitored
for safety and efficacy within the primary treatment protocols for the protocol defined
duration. While every effort will be made to keep patients in follow-up within the respective
treatment protocol itself, patients can drop off treatment protocols at any time. Patients
discontinuing from the primary treatment protocols for any reason will be enrolled in this
long term follow up (LTFU). This will allow collecting data on long term safety and efficacy
(as applicable) as mandated by the health authorities of all patients treated with CD19 CART
therapy within the concept of a single protocol.
Collection of such long term effects of CD19 CART cell therapy will help to further define
the risk-benefit profile of CD19 CART.
Inclusion Criteria:
- All patients who have received anti-CD19 directed CART therapy and completed or
discontinued early from a Novartis sponsored treatment protocol that utilized
CD19-directed CART cells or from any CD19 CART trial sponsored by the University of
Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR
technology.
- Patients who have provided informed consent for the long term follow up study prior to
their study participation .
Exclusion Criteria:
- There are no specific exclusion criteria for this study.
We found this trial at
    23
    sites
	
								Salt Lake City, Utah 84108			
	
			
					Principal Investigator: Michael Boyer, MD
			
						
										Phone: 801-213-3395
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									3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
	
			Cincinnati, Ohio 45229
 1-513-636-4200  
							
					Principal Investigator: Stella M. Davies
			
						
										Phone: 513-636-9292
					
		Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...  
  
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									3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
	
			Portland, Oregon 97239
503 494-8311 
							
					Principal Investigator: Brandon Hayes-Lattin
			
						
										Phone: 503-346-1507
					
		Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...  
  
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									1500 East Medical Center Drive
Ann Arbor, Michigan 48109
	
			
					Ann Arbor, Michigan 48109
Principal Investigator: John Magenau
			
						
										Phone: 734-936-8538
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									500 S State St
Ann Arbor, Michigan 48109
	
			Ann Arbor, Michigan 48109
(734) 764-1817 
							
					Principal Investigator: Gregory Yanik
			
						
								
		University of Michigan The University of Michigan was founded in 1817 as one of the...  
  
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								Atlanta, Georgia 30308			
	
			
					Principal Investigator: Jonathon Cohen
			
						
										Phone: 404-778-3708
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								Atlanta, Georgia 30342			
	
			
					Principal Investigator: Muna Qayed
			
						
										Phone: +1 404 785 2125
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								Chicago, Illinois 60637			
	
			
					Principal Investigator: Michael R. Bishop
			
						
										Phone: 773-834-0982
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								Columbus, Ohio 43210			
	
			
					Principal Investigator: Samantha Jaglowski
			
						
										Phone: 614-688-9494
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								Dallas, Texas 75235			
	
			
					Principal Investigator: Theodore Laetsch, MD
			
						
										Phone: 214-456-2726
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								Durham, North Carolina 27705			
	
			
					Principal Investigator: Paul L. Martin
			
						
										Phone: 919-668-2967
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								Houston, Texas 77030			
	
			
					Principal Investigator: Jason Westin
			
						
										Phone: 713-792-2171
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								Kansas City, Missouri 64108			
	
			
					Principal Investigator: Gary Myers, MD
			
						
										Phone: 816-302-6851
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								Los Angeles, California 90027			
	
			
					Principal Investigator: Michael Pulsipher
			
						
										Phone: 323-361-8670
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									600 Highland Ave
Madison, Wisconsin 53792
	
			Madison, Wisconsin 53792
(608) 263-6400
							
					Principal Investigator: Christian Capitini
			
						
										Phone: 608-890-8070
					
		University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...  
  
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								Minneapolis, Minnesota 55455			
	
			
					Principal Investigator: Veronika Bachanova
			
						
										Phone: 612-625-1610
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								Philadelphia, Pennsylvania 19104			
	
			
					Principal Investigator: Stephan Grupp
			
						
										Phone: 267-425-5837
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									3451 Walnut St
Philadelphia, Pennsylvania 19104
	
			Philadelphia, Pennsylvania 19104
1 (215) 898-5000 
							
					Principal Investigator: Noelle Frey
			
						
										Phone: 215-898-9256
					
		Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...  
  
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									13400 East Shea Boulevard
Phoenix, Arizona 85054
	
			
					Phoenix, Arizona 85054
Principal Investigator: Jose F. Leis
			
						
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								San Francisco, California 94115			
	
			
					Principal Investigator: Charalambos Andreadis
			
						
										Phone: 415-514-6281
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								Westwood, Kansas 66205			
	
			
					Principal Investigator: Joseph P McGuirk
			
						
										Phone: 913-588-6029
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