Actively Recruiting

Phase 3
Age: 0Years - 100Years
All Genders
NCT02445222

CAR-T Long Term Follow Up (LTFU) Study

Led by Novartis Pharmaceuticals · Updated on 2025-10-28

1400

Participants Needed

118

Research Sites

1059 weeks

Total Duration

On this page

Sponsors

N

Novartis Pharmaceuticals

Lead Sponsor

U

University of Pennsylvania

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 CAR-T therapied for 15 years following their last CAR-T (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.

CONDITIONS

Official Title

CAR-T Long Term Follow Up (LTFU) Study

Who Can Participate

Age: 0Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have received CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol or any CAR-T trial by the University of Pennsylvania partnered with Novartis
  • Patients who have given informed consent before joining the long term follow-up study
Not Eligible

You will not qualify if you...

  • There are no specific exclusion criteria for this study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 118 locations

1

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

Completed

2

City of Hope National Medical Center

Duarte, California, United States, 91010 3000

Actively Recruiting

3

Childrens Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

4

UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

5

UCSF Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

6

Stanford University Medical Center

Stanford, California, United States, 94304

Actively Recruiting

7

Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

8

Emory University School of Medicine/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

9

Childrens Healthcare of Atlanta

Atlanta, Georgia, United States, 30342

Actively Recruiting

10

Uni of Chi Medi Ctr Hema and Onco

Chicago, Illinois, United States, 60637

Actively Recruiting

11

University of Chicago Medical Center, Hematology & Oncology

Chicago, Illinois, United States, 60637

Actively Recruiting

12

University of Kansas Cancer Center SC

Westwood, Kansas, United States, 66205

Actively Recruiting

13

University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

Actively Recruiting

14

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

15

Beth Israel Deaconess Med Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

16

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

17

University of Michigan

Ann Arbor, Michigan, United States, 48109-2800

Actively Recruiting

18

Uni Of Michigan Health System

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

19

University of Michigan Health System SC CTL019

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

20

Wayne State University-Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

21

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Withdrawn

22

Children s Mercy Hospital

Kansas City, Missouri, United States, 64108

Actively Recruiting

23

Children's Mercy Hospital SC

Kansas City, Missouri, United States, 64108

Actively Recruiting

24

Weill Cornell Medical College

New York, New York, United States, 10065

Withdrawn

25

Duke Unversity Medical Center SC - CTL019B2205J

Durham, North Carolina, United States, 27705

Actively Recruiting

26

Duke Unversity Medical Center

Durham, North Carolina, United States, 27705

Actively Recruiting

27

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229-3039

Actively Recruiting

28

Cinn Children Hosp Medical Center

Cincinnati, Ohio, United States, 45229-3039

Actively Recruiting

29

Ohio ST Compr Cancer Ctr James Hosp

Columbus, Ohio, United States, 43210

Actively Recruiting

30

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

31

Oregon Health Sciences University

Portland, Oregon, United States, 97239

Actively Recruiting

32

The Childrens Hosp of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

33

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

34

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

35

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

36

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

37

UTSW/Children's Medical Center

Dallas, Texas, United States, 75235

Actively Recruiting

38

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

39

MD Anderson Cancer Center SC

Houston, Texas, United States, 77030

Actively Recruiting

40

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

41

University of Utah Clinical Trials Office

Salt Lake City, Utah, United States, 84108

Actively Recruiting

42

University of Utah Clinical Trials Office

Salt Lake City, Utah, United States, 84108

Actively Recruiting

43

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States, 53792

Actively Recruiting

44

University of Wisconsin Hospital

Madison, Wisconsin, United States, 53792

Actively Recruiting

45

Novartis Investigative Site

Camperdown, New South Wales, Australia, 2050

Actively Recruiting

46

Novartis Investigative Site

Melbourne, Victoria, Australia, 3000

Actively Recruiting

47

Novartis Investigative Site

Melbourne, Victoria, Australia, 3004

Actively Recruiting

48

Novartis Investigative Site

Parkville, Victoria, Australia, 3052

Withdrawn

49

Novartis Investigative Site

Murdoch, Western Australia, Australia, 6150

Actively Recruiting

50

Novartis Investigative Site

Herston, Australia, QLD 4006

Actively Recruiting

51

Novartis Investigative Site

Linz, Austria, 4020

Withdrawn

52

Novartis Investigative Site

Salzburg, Austria, 5020

Actively Recruiting

53

Novartis Investigative Site

Vienna, Austria, 1090

Actively Recruiting

54

Novartis Investigative Site

Vienna, Austria, A 1090

Actively Recruiting

55

Novartis Investigative Site

Ghent, Belgium, 9000

Actively Recruiting

56

Novartis Investigative Site

Hamilton, Ontario, Canada, L8V 1C3

Actively Recruiting

57

Novartis Investigative Site

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

58

Novartis Investigative Site

Montreal, Quebec, Canada, H1T 2M4

Actively Recruiting

59

Novartis Investigative Site

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

60

Novartis Investigative Site

Beijing, China, 100036

Actively Recruiting

61

Novartis Investigative Site

Copenhagen, Denmark, DK-2100

Actively Recruiting

62

Novartis Investigative Site

Helsinki, Finland, 00029

Actively Recruiting

63

Novartis Investigative Site

Nantes, France, 44093

Actively Recruiting

64

Novartis Investigative Site

Paris, France, 75019

Actively Recruiting

65

Novartis Investigative Site

Paris, France, 75475

Actively Recruiting

66

Novartis Investigative Site

Pierre-Bénite, France, 69495

Actively Recruiting

67

Novartis Investigative Site

Villejuif, France, 94800

Actively Recruiting

68

Novartis Investigative Site

Munich, Bavaria, Germany, 81377

Actively Recruiting

69

Novartis Investigative Site

Regensburg, Bavaria, Germany, 93053

Actively Recruiting

70

Novartis Investigative Site

Würzburg, Bavaria, Germany, 97080

Actively Recruiting

71

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany, 60590

Actively Recruiting

72

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany, 50937

Actively Recruiting

73

Novartis Investigative Site

Leipzig, Saxony, Germany, 04103

Actively Recruiting

74

Novartis Investigative Site

Berlin, Germany, 13353

Actively Recruiting

75

Novartis Investigative Site

Hamburg, Germany, 20246

Actively Recruiting

76

Novartis Investigative Site

Ulm, Germany, 89081

Actively Recruiting

77

Novartis Investigative Site

Chaïdári, Greece, 124 62

Actively Recruiting

78

Novartis Investigative Site

Hong Kong, Hong Kong

Actively Recruiting

79

Novartis Investigative Site

Ramat Gan, Israel, 5265601

Actively Recruiting

80

Novartis Investigative Site

Tel Aviv, Israel, 6423906

Actively Recruiting

81

Novartis Investigative Site

Bologna, BO, Italy, 40138

Actively Recruiting

82

Novartis Investigative Site

Monza, MB, Italy, 20900

Actively Recruiting

83

Novartis Investigative Site

Milan, MI, Italy, 20132

Actively Recruiting

84

Novartis Investigative Site

Milan, MI, Italy, 20133

Actively Recruiting

85

Novartis Investigative Site

Rozzano, MI, Italy, 20089

Actively Recruiting

86

Novartis Investigative Site

Roma, RM, Italy, 00165

Actively Recruiting

87

Novartis Investigative Site

Roma, RM, Italy, 00168

Actively Recruiting

88

Novartis Investigative Site

Fukuoka, Fukuoka, Japan, 812-8582

Actively Recruiting

89

Novartis Investigative Site

Sapporo, Hokkaido, Japan, 060 8648

Actively Recruiting

90

Novartis Investigative Site

Sendai, Miyagi, Japan, 980 8574

Actively Recruiting

91

Novartis Investigative Site

Chuo Ku, Tokyo, Japan, 104 0045

Withdrawn

92

Novartis Investigative Site

Kyoto, Japan, 606 8507

Actively Recruiting

93

Novartis Investigative Site

Amsterdam, North Holland, Netherlands, 1105 AZ

Completed

94

Novartis Investigative Site

Utrecht, Netherlands, 3584 CS

Completed

95

Novartis Investigative Site

Utrecht, Netherlands, 3584 CX

Withdrawn

96

Novartis Investigative Site

Oslo, Norway, 0310

Actively Recruiting

97

Novartis Investigative Site

Oslo, Norway, 0424

Actively Recruiting

98

Novartis Investigative Site

Riyadh, Saudi Arabia, 11211

Actively Recruiting

99

Novartis Investigative Site

Singapore, Singapore, 119074

Actively Recruiting

100

Novartis Investigative Site

Singapore, Singapore, 169608

Actively Recruiting

101

Novartis Investigative Site

Seoul, South Korea, 03080

Actively Recruiting

102

Novartis Investigative Site

Seoul, South Korea, 03722

Actively Recruiting

103

Novartis Investigative Site

Seoul, South Korea, 05505

Actively Recruiting

104

Novartis Investigative Site

Seoul, South Korea, 06351

Actively Recruiting

105

Novartis Investigative Site

Esplugues, Barcelona, Spain, 08950

Actively Recruiting

106

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Actively Recruiting

107

Novartis Investigative Site

Salamanca, Castille and León, Spain, 37007

Actively Recruiting

108

Novartis Investigative Site

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

109

Novartis Investigative Site

Pamplona, Navarre, Spain, 31008

Actively Recruiting

110

Novartis Investigative Site

Barcelona, Spain, 08041

Actively Recruiting

111

Novartis Investigative Site

Madrid, Spain, 28009

Actively Recruiting

112

Novartis Investigative Site

Madrid, Spain, 28041

Actively Recruiting

113

Novartis Investigative Site

Madrid, Spain, 28046

Actively Recruiting

114

Novartis Investigative Site

Seville, Spain, 41013

Actively Recruiting

115

Novartis Investigative Site

Valencia, Spain, 46010

Actively Recruiting

116

Novartis Investigative Site

Taipei, Taiwan, 10002

Actively Recruiting

117

Novartis Investigative Site

Birmingham, United Kingdom, B15 2TH

Actively Recruiting

118

Novartis Investigative Site

London, United Kingdom, SE5 9RS

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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