B-Cell Acute Lymphoblastic LeukemiaPhase 2CASSIOPEIANCT03876769
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
A Phase 2 study testing CTL019 in people with B-Cell Acute Lymphoblastic Leukemia, run by Novartis Pharmaceuticals at 43 sites in 11 countries.
Trial summary
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- B-Cell Acute Lymphoblastic Leukemia
- What is being tested?
- CTL019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 43 sitesin 11 countries
- Study dates
- 24 Jun 2019to 19 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CD19 expressing B-cell Acute Lymphoblastic Leukemia
- 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.
- Age 1 to 25 years at the time of screening
- Lansky (age < 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60%
- Adequate organ function during the screening period:
- 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)
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- 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
- 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.
Who cannot join
- M3 marrow at the completion of 1st line induction therapy
- 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.
- Philadelphia chromosome positive ALL
- Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence of a hypodiploid clone
- Prior tyrosine kinase inhibitor therapy
- 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.
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- 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)
- 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.
Trial locations and contacts
43 sites in 11 countries.
43 sites in 11 countries
United States30 sites
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30342
Childrens Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
Children s Hospital of Alabama
Birmingham, Alabama, 35233
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Cinn Children Hosp Medical Center
Cincinnati, Ohio, 45229-3039
Univ of Texas Southwest Med Center
Dallas, Texas, 75390-9034
City of Hope National Medical
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
Hackensack Uni Medical Center
Hackensack, New Jersey, 07601
Texas Childrens Cancer and Hematology Center
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202-5225
Children s Mercy Hospital
Kansas City, Missouri, 64108
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Mattel Childrens Hospital UCLA
Los Angeles, California, 90095
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
Childrens Hospital of Orange County
Orange, California, 92868-3874
The Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Oregon Health and Science University
Portland, Oregon, 97239-3098
University of Utah Clinical Trials Office
Salt Lake City, Utah, 84108
Methodist Childrens Hospital
San Antonio, Texas, 78229
Rady Children s Hospital
San Diego, California, 92123
UCSF Medical Center
San Francisco, California, 94143
Johns Hopkins All Childrens
St. Petersburg, Florida, 33701
Stanford University Medical Center
Stanford, California, 94304
Childrens National Hospital
Washington D.C., District of Columbia, 20010
Canada3 sites
Novartis Investigative Site
Calgary, Alberta, T3B 6A8
Novartis Investigative Site
Montreal, Quebec, H3T 1C5
Novartis Investigative Site
Toronto, Ontario, M5G 1X8
United Kingdom2 sites
Novartis Investigative Site
London, NW1 2BU
Novartis Investigative Site
London, WC1N 3JH
About this study
Official title: A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment \& follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.
- Conditions
- B-Cell Acute Lymphoblastic Leukemia
- Being tested
- CTL019
- Keywords
- CTL019, Kymriah, B-Cell Acute Lymphoblastic Leukemia, ALL, tisagenlecleucel, HR B-ALL EOC MRD, Minimal Residual Disease (MRD), Positive at the End of Consolidation (EOC)
- Medical subject headings
- Burkitt Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTL019Biological
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
| Study group | Role | What they receive |
|---|---|---|
| Single dose of CTL019 | Experimental | 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 Receives: Biological: CTL019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS) rate without censoring for new anticancer therapy, including Stem Cell Transplantation (SCT) while in remission
DFS is defined as the time from the date of tisagenlecleucel infusion to the date of the first documented morphological relapse, occurrence of secondary malignancy or death due to any cause. Participants are not censored at the start of subsequent anticancer therapy or SCT while in remission.
Measured: 5 years after tisagenlecleucel infusion
Overall Survival (OS) rate
OS is defined as the time from date of first tisagenlecleucel infusion to the date of death due to any reason.
Measured: 4 years after tisagenlecleucel
Secondary outcomes (28)
Percentage of participants who are disease free without allogeneic stem cell transplant (SCT)
Minimal Residual Disease (MRD) negative remission (complete remission (CR) or Complete remission with incomplete blood count recovery CRi)) at Month 12 without SCT after tisagenlecleucel infusion.
Measured: 12 months after last infusion
DFS rate with censoring for new anticancer therapy, including SCT, while in remission
Assessing the effect of tisagenlecleucel on DFS if new anticancer therapy is not available.
Measured: 5 years
Percentage of participants achieving MRD negative CR or CRi at Month 3
Assessing the percentage of participants who achieved MRD negative complete response (CR) or Complete remission with incomplete blood count recovery (CRi) status as determined by central laboratory using multi-parameter flow cytometry.
Measured: 3 months after the tisagenlecleucel infusion.
Pediatric Quality of Life (PedsQL)
Patient reported outcome to assess quality of life in patients aged 8 and above. The 23 items PedQL (Pediatrics Quality of Life Inventory) measure core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning.
Items measured include 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items).
Each item is measured on a 5 point Likert scale with 0 indicating "never" and 4 indicating "almost always".
The Likert scores are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 5=25, and 4=0. A higher score indicates better health-related quality of life (HRQoL).
Measured: 5 years
European Quality of Life 5 dimensions (EQ-5D-3L & EQ-5D-Y))
Patient reported outcome to assess health status in patients aged 8 and above. The EQ-5D (European Quality of Life -5 Dimensions) measures a wide range of health conditions and treatments; it is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale (EQ-visual analogue scale [EQ-VAS]) that records the patient's self-rated overall health state.
Respondents rate each of these 5 dimensions from "no problem", "some problem," or "extreme problem".
The EQ-VAS records the respondents' self-related health on a vertical, visual analogue scale. The range for EQ-VAS is from 0 (=the worst health you can imagine) to 100 (=the best health you can imagine).
Measured: 5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Detection test
Speed of performance (mean of the log10 transformed reaction times for correct responses)
Measured: 5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Identification test
This test measures the speed of performance (mean of the log10 transformed reaction times for correct responses)
Measured: 5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Groton Maze Learning test
This test looks at the total number of errors made in attempting to learn the hidden pathways during a single session.
Measured: 5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: One Back test
This test measures the accuracy of performance (arcsine transformation of the square root of the percentage of correct responses). The test also measures the speed of performance (mean of the log10 transformed reaction times for correct responses).
Measured: 5 years
Impact of tisagenlecleucel on cognitive functioning usingComputerized neurocognitive assessment: One card learning test
This test measures the accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).
Measured: 5 years
Percentage of participants with pre-existing antibodies
Prevalence of immunogenicity
Measured: 8 years
Percentage of participants with anti-m CAR19 antibodies post infusion with tisagenlecleucel and % of patients without measureable anti-mCAR19 antibodies
Incidence of immunogenicity
Measured: 8 years
Percentage of patients that have measureable anti-mCAR19 antibodies above patient specific cut-point (reported as a %) pre and post tisagenlecleucel infusion categorized by Day 28 response
Impact of immunogenicity on clinical response
Measured: 8 years
tisagenlecleucel transgene concentration
Transgene concentration as detected by qPCR in target tissue
Measured: 8 years
Expression of tisagenlecleucel
Summary of tisagenlecleucel CAR-positive viable T cells measured by flow cytometry in target tissue
Measured: 8 years
Persistence of CAR (reported as copies/ug) categorized by the time to B-cell recovery (recovery < 3 months, >3 months to < 6months, > 6 months)
Relationship between B-cell recovery and transgene levels
Measured: 8 years
Cmax; cellular kinetic parameter of tisagenlecleucel
Cmax is the maximum (peak) observed peripheral blood or other body fluid drug concentration after single dose administration.
Measured: 8 years
Tmax; cellular kinetic parameter of tisagenlecleucel
Tmax is the time to maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
Measured: 8 years
AUC0-29d and 84d; cellular kinetic parameter of tisagenlecleucel
The AUC from time zero to day 29 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days )
Measured: 8 years
AUC0-Tmax; cellular kinetic parameter of tisagenlecleucel
The AUC from time zero to Tmax in peripheral blood (% or copies/μg x days)
Measured: 8 years
T1/2; cellular kinetic parameter of tisagenlecleucel
The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Measured: 8 years
Clast; cellular kinetic parameter of tisagenlecleucel
The last observed quantifiable concentration in peripheral blood (% or copies/μg)
Measured: 8 years
Tlast; cellular kinetic parameter of tisagenlecleucel
The time of last observed quantifiable concentration in peripheral blood (days)
Measured: 8 years
Impact of tisagenlecleucel dose on day 29 response
Clinical response summarized by quartile of administered doses
Measured: 8 years
AUC 0 - 29d; cellular kinetic parameter of tisagenlecleucel
Impact of tisagenlecleucel exposure on day 29 response; The AUC from time zero to day 29 in peripheral blood (% or copies/μg x days )
Measured: Day 29
Cmax: cellular kinetic parameter of tisagenlecleucel
Impact of tisagenlecleucel exposure on day 29 response; The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/μg)
Measured: Day 29
Tmax: cellular kinetic parameter of tisagenlecleucel
Impact of tisagenlecleucel exposure on day 29 response; The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
Measured: Day 29
T1/2: cellular kinetic parameter of tisagenlecleucel
Impact of tisagenlecleucel exposure on day 29 response; The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start24 Jun 2019
- Primary completion19 Oct 2027 (estimated)
- Study completion19 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for B-Cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Oncology Group
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876769
- Sponsor's protocol ID
- CCTL019G2201J
- Other IDs
- 2017-002116-14, 2023-508081-15-00, 2023, 2017
- Acronym
- CASSIOPEIA
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2018
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
- Expanded access
- Available
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463Seftel 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.
PubMed 32589970
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy
- ClinicalTrials.gov ID
- NCT03876769
- Acronym / sponsor ID
- CASSIOPEIA / CCTL019G2201J
- Conditions
- B-Cell Acute Lymphoblastic Leukemia
- Keywords
- CTL019, Kymriah, B-Cell Acute Lymphoblastic Leukemia, ALL, tisagenlecleucel, HR B-ALL EOC MRD, Minimal Residual Disease (MRD), Positive at the End of Consolidation (EOC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Children's Oncology Group
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 19 Oct 2027 (estimated)
- Study completion
- 19 Oct 2027 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment \& follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose of CTL019 | Experimental | Biological: CTL019Based 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 |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- CD19 expressing B-cell Acute Lymphoblastic Leukemia
- 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.
- Age 1 to 25 years at the time of screening
- Lansky (age < 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60%
- Adequate organ function during the screening period:
Key exclusion criteria (9 listed)
- M3 marrow at the completion of 1st line induction therapy
- 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.
- Philadelphia chromosome positive ALL
- Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence of a hypodiploid clone
- Prior tyrosine kinase inhibitor therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTL019Based 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 | Biological | Single dose of CTL019 |
Primary outcome
Disease Free Survival (DFS) rate without censoring for new anticancer therapy, including Stem Cell Transplantation (SCT) while in remission
Time frame: 5 years after tisagenlecleucel infusion
DFS is defined as the time from the date of tisagenlecleucel infusion to the date of the first documented morphological relapse, occurrence of secondary malignancy or death due to any cause. Participants are not censored at the start of subsequent anticancer therapy or SCT while in remission.
Overall Survival (OS) rate
Time frame: 4 years after tisagenlecleucel
OS is defined as the time from date of first tisagenlecleucel infusion to the date of death due to any reason.
28 secondary outcomes
Percentage of participants who are disease free without allogeneic stem cell transplant (SCT)
Time frame: 12 months after last infusion
DFS rate with censoring for new anticancer therapy, including SCT, while in remission
Time frame: 5 years
Percentage of participants achieving MRD negative CR or CRi at Month 3
Time frame: 3 months after the tisagenlecleucel infusion.
Pediatric Quality of Life (PedsQL)
Time frame: 5 years
European Quality of Life 5 dimensions (EQ-5D-3L & EQ-5D-Y))
Time frame: 5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Detection test
Time frame: 5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Identification test
Time frame: 5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: Groton Maze Learning test
Time frame: 5 years
Impact of tisagenlecleucel on cognitive functioning using Computerized neurocognitive assessment: One Back test
Time frame: 5 years
Impact of tisagenlecleucel on cognitive functioning usingComputerized neurocognitive assessment: One card learning test
Time frame: 5 years
Percentage of participants with pre-existing antibodies
Time frame: 8 years
Percentage of participants with anti-m CAR19 antibodies post infusion with tisagenlecleucel and % of patients without measureable anti-mCAR19 antibodies
Time frame: 8 years
Percentage of patients that have measureable anti-mCAR19 antibodies above patient specific cut-point (reported as a %) pre and post tisagenlecleucel infusion categorized by Day 28 response
Time frame: 8 years
tisagenlecleucel transgene concentration
Time frame: 8 years
Expression of tisagenlecleucel
Time frame: 8 years
Persistence of CAR (reported as copies/ug) categorized by the time to B-cell recovery (recovery < 3 months, >3 months to < 6months, > 6 months)
Time frame: 8 years
Cmax; cellular kinetic parameter of tisagenlecleucel
Time frame: 8 years
Tmax; cellular kinetic parameter of tisagenlecleucel
Time frame: 8 years
AUC0-29d and 84d; cellular kinetic parameter of tisagenlecleucel
Time frame: 8 years
AUC0-Tmax; cellular kinetic parameter of tisagenlecleucel
Time frame: 8 years
T1/2; cellular kinetic parameter of tisagenlecleucel
Time frame: 8 years
Clast; cellular kinetic parameter of tisagenlecleucel
Time frame: 8 years
Tlast; cellular kinetic parameter of tisagenlecleucel
Time frame: 8 years
Impact of tisagenlecleucel dose on day 29 response
Time frame: 8 years
AUC 0 - 29d; cellular kinetic parameter of tisagenlecleucel
Time frame: Day 29
Cmax: cellular kinetic parameter of tisagenlecleucel
Time frame: Day 29
Tmax: cellular kinetic parameter of tisagenlecleucel
Time frame: Day 29
T1/2: cellular kinetic parameter of tisagenlecleucel
Time frame: Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
- Derived from this study: PubMed 32589970Seftel 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.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
43 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTL019 in people with B-Cell Acute Lymphoblastic Leukemia, run by Novartis Pharmaceuticals at 43 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Canada, United Kingdom, Belgium, Denmark and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) rate without censoring for new anticancer therapy, including Stem Cell Transplantation (SCT) while in remission (time frame: 5 years after tisagenlecleucel infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876769, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.