Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
NCT ID: NCT03876769
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
122 participants
INTERVENTIONAL
2019-06-24
2027-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single dose of 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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. De novo NCI HR B-ALL who received first-line treatment and are MRD ≥ 0.01% at EOC. EOC bone marrow MRD will be collected prior to screening and will be assessed by multi-parameter flow cytometry using central laboratory analysis.
3. Age 1 to 25 years at the time of screening
4. Lansky (age \< 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60%
5. Adequate organ function during the screening period:
A. Renal function based on age/gender B. ALT ≤ 5 times ULN for age C. AST ≤ 5 times ULN for age D. Total bilirubin \< 2 mg/dL (for Gilbert's Syndrome subjects total bilirubin \< 4 mg/dL)
E. Adequate pulmonary function defined as:
* no or mild dyspnea (≤ Grade 1)
* oxygen saturation of \> 90% on room air F. Adequate cardiac function defined as LVSF ≥ 28% confirmed by echocardiogram or LVEF ≥ 45% confirmed by echocardiogram or MUGA within 6 weeks of screening
6. Prior induction and consolidation chemotherapy allowed: 1st line subjects: ≤ 3 blocks of standard chemotherapy for first-line B-ALL, defined as 4-drug induction, Berlin-Frankfurt-Münster (BFM) consolidation or Phase 1b, and interim maintenance with high-dose methotrexate.
Exclusion Criteria
2. M2 or M3 marrow or persistent extramedullary disease at the completion of first-line consolidation therapy or evidence of disease progression in the peripheral blood or new extramedullary disease prior to enrollment. Patients with previous CNS disease are eligible if there is no active CNS involvement of leukemia at the time of screening.
3. Philadelphia chromosome positive ALL
4. Hypodiploid: less than 44 chromosomes and/or DNA index \< 0.81, or other clear evidence of a hypodiploid clone
5. Prior tyrosine kinase inhibitor therapy
6. Subjects with concomitant genetic syndromes associated with bone marrow failure states: such as subjects with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Subjects with Down syndrome will not be excluded.
7. Subjects with Burkitt's lymphoma/leukemia (i.e. subjects with mature B-ALL, leukemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation)
8. Has had treatment with any prior anti-CD19 therapy 9. Treatment with any prior gene or engineered T cell therapy
Other protocol-defined inclusion/exclusion may apply.
1 Year
25 Years
ALL
No
Sponsors
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Children's Oncology Group
NETWORK
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Children s Hospital of Alabama
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
City of Hope National Medical
Duarte, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Mattel Childrens Hospital UCLA
Los Angeles, California, United States
Childrens Hospital of Orange County
Orange, California, United States
Rady Children s Hospital
San Diego, California, United States
UCSF Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Childrens National Hospital
Washington D.C., District of Columbia, United States
Johns Hopkins All Childrens
St. Petersburg, Florida, United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States
James Whitcomb Riley Hospital For Children
Indianapolis, Indiana, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Children s Mercy Hospital
Kansas City, Missouri, United States
Hackensack Uni Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cinn Children Hosp Medical Center
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
The Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Univ of Texas Southwest Med Center
Dallas, Texas, United States
Texas Children's Cancer and Hematology Center
Houston, Texas, United States
Methodist Childrens Hospital
San Antonio, Texas, United States
University of Utah Clinical Trials Office
Salt Lake City, Utah, United States
University of Wisconsin Hospital and Clinics Pharmacy/Drug Shipping Address
Madison, Wisconsin, United States
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Copenhagen, , Denmark
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Roma, RM, Italy
Prinses Maxima Centrum voor Kinderoncologie
Utrecht, CS, Netherlands
Novartis Investigative Site
Utrecht, , Netherlands
Novartis Investigative Site
Oslo, , Norway
Novartis Investigative Site
Esplugues, Barcelona, Spain
Novartis Investigative Site
Gothenburg, , Sweden
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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References
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Seftel MD. Hyper-CVAD: a regimen for all seasons. Lancet Haematol. 2020 Jul;7(7):e501-e502. doi: 10.1016/S2352-3026(20)30179-4. No abstract available.
Other Identifiers
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2017-002116-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCTL019G2201J
Identifier Type: -
Identifier Source: org_study_id
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