NCT03876769 - Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients | Biotech Hunter

Enrollment

122

Participants

Timeline

Start Date

June 24, 2019

Primary Completion Date

August 20, 2025

Study Completion Date

October 19, 2027

Conditions

B-Cell Acute Lymphoblastic Leukemia

Interventions

BIOLOGICAL

CTL019

"Based on the subject's weight, one of two possible dose ranges will be prepared for the subject:~Subjects ≤ 50 kg: 0.2 to 5.0 x 10(6) CAR-positive viable T cells per kg body weight~OR~Subjects \> 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells"

Trial Locations (45)

3584

Prinses Maxima Centrum voor Kinderoncologie, Utrecht

9000

Novartis Investigative Site, Ghent

10065

Memorial Sloan Kettering Cancer Ctr, New York

14263

Roswell Park Cancer Institute, Buffalo

19104

The Childrens Hosp of Philadelphia, Philadelphia

20010

Childrens National Hospital, Washington D.C.

21231

Johns Hopkins Oncology Center, Baltimore

27710

Duke University Medical Center, Durham

30342

Childrens Healthcare of Atlanta, Atlanta

33701

Johns Hopkins All Childrens, St. Petersburg

35233

Children s Hospital of Alabama, Birmingham

46202

James Whitcomb Riley Hospital For Children, Indianapolis

53226

Childrens Hospital of Wisconsin, Milwaukee

53792

University of Wisconsin Hospital and Clinics Pharmacy/Drug Shipping Address, Madison

64108

Children s Mercy Hospital, Kansas City

75019

Novartis Investigative Site, Paris

77030

Texas Children's Cancer and Hematology Center, Houston

78229

Methodist Childrens Hospital, San Antonio

80045

Childrens Hospital Colorado, Aurora

84108

University of Utah Clinical Trials Office, Salt Lake City

85016

Phoenix Children s Hospital, Phoenix

90027

Childrens Hospital Los Angeles, Los Angeles

90095

Mattel Childrens Hospital UCLA, Los Angeles

91010

City of Hope National Medical, Duarte

92123

Rady Children s Hospital, San Diego

94143

UCSF Medical Center, San Francisco

94304

Stanford University Medical Center, Stanford

110032

Columbia University Medical Center, New York

92868-3874

Childrens Hospital of Orange County, Orange

02215

Dana Farber Cancer Institute, Boston

07601

Hackensack Uni Medical Center, Hackensack

45229-3039

Cinn Children Hosp Medical Center, Cincinnati

97239-3098

Oregon Health and Science University, Portland

75390-9034

Univ of Texas Southwest Med Center, Dallas

T3B 6A8

Novartis Investigative Site, Calgary

M5G 1X8

Novartis Investigative Site, Toronto

H3T 1C5

Novartis Investigative Site, Montreal

DK-2100

Novartis Investigative Site, Copenhagen

00165

Novartis Investigative Site, Roma

3584 CS

Novartis Investigative Site, Utrecht

0424

Novartis Investigative Site, Oslo

08950

Novartis Investigative Site, Esplugues

SE 416 85

Novartis Investigative Site, Gothenburg

NW1 2BU

Novartis Investigative Site, London

WC1N 3JH

Novartis Investigative Site, London