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Clinical trials for Tisagenlecleucel

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: Tisagenlecleucel. Displaying page 1 of 1.
    EudraCT Number: 2017-002116-14 Sponsor Protocol Number: CCTL019G2201J Start Date*: 2018-10-22
    Sponsor Name:Novartis Pharma AG
    Full 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...
    Medical condition: Pediatric and young adult patients aged 1 to 25 years with first-line NCI high-risk (HR) B-cell acute lymphoblastic leukemia (B-ALL) who are in CR1 with minimal residual disease (MRD) positive (MR...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    21.0 100000004864 10063621 Acute lymphoblastic leukaemia recurrent LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) ES (Temporarily Halted) DK (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Completed) FI (Completed) NL (Trial now transitioned) NO (Trial now transitioned) SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003035-28 Sponsor Protocol Number: APHP200132 Start Date*: 2022-02-22
    Sponsor Name:Assistance Publique - Hôpitaux de Paris
    Full Title: " Combination of an Anti-PD1 antibody with Tisagenlecleucel Reinfusion in children, adolescents and young adults with Acute Lymphoblastic Leukemia after loss of persistence " CAPTiRALL
    Medical condition: Relapsed or refractory B-ALL (any relapse after HSCT, 2nd relapse or later, refractory ALL), aged 1-25 years old, previously treated by Tisagenlecleucel (Kymriah ®), Cohort 1 presenting early loss ...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004385-94 Sponsor Protocol Number: CCTL019E2202 Start Date*: 2018-07-30
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed follicular lymphoma
    Medical condition: Adult patients with refractory or relapsed follicular lymphoma
    Disease: Version SOC Term Classification Code Term Level
    24.0 10016903 - Follicle centre lymphomas, follicular grade I, II, III 10016903 Follicle centre lymphomas, follicular grade I, II, III HLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061170 Follicle centre lymphoma, follicular grade I, II, III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) GB (GB - no longer in EU/EEA) AT (Completed) ES (Ongoing) DE (Trial now transitioned) FR (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001535-99 Sponsor Protocol Number: CCTL019BUS03 Start Date*: 2022-03-14
    Sponsor Name:Novartis Pharmaceuticals Corporation
    Full Title: A phase II, open label, multi-center trial to determine the efficacy and safety of tisagenlecleucel re-infusion in Pediatric and Adolescent Young Adult (AYA) patients with acute lymphoblastic leuke...
    Medical condition: Paediatric patients with B-cell acute lymphoblastic leukaemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002966-29 Sponsor Protocol Number: CCTL019H2301 Start Date*: 2018-11-22
    Sponsor Name:Novartis Pharma AG
    Full Title: Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA)
    Medical condition: adult patients with aggressive B-cell NHL after failure of rituximab and anthracycline containing first line immunochemotherapy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) NL (Trial now transitioned) BE (Completed) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-005019-15 Sponsor Protocol Number: CCTL019C2202 Start Date*: 2018-11-08
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A Phase II, single arm, multicenter open label trial to determine the safety and efficacy of tisagenlecleucel in pediatric patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma (N...
    Medical condition: pediatric and adolescents patients with CD19positive r/r mature B-cell NHL who have relapsed after one or more prior therapies or are primary refractory.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Completed) DE (Completed) SE (Ongoing) DK (Completed) NO (Completed) AT (Completed) GB (GB - no longer in EU/EEA) NL (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002930-35 Sponsor Protocol Number: Uni-Koeln-3903 Start Date*: 2021-02-22
    Sponsor Name:Univeristy of Cologne
    Full Title: Phase II trial of TisaGenlecleucel in Elderly Patients with First-Relapsed or Primary Refractory Agressive B-cell Non-Hodgkin Lymphoma
    Medical condition: malignant disease of lymphnodes especially refractory and non-responding aggressive non Hodgkin lymphoma; Diffuse large B cell lymphoma (DLBCL)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029601 Non-Hodgkin's lymphoma refractory PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003736-13 Sponsor Protocol Number: CCTL019B2205J Start Date*: 2017-09-29
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Phase II, single arm, multicenter trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia
    Medical condition: Paediatric patients with B-cell acute lymphoblastic leukaemia and lymphoma who are refractory, relapsed to prior treatments
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001991-31 Sponsor Protocol Number: CCTL019B2001X Start Date*: 2017-03-02
    Sponsor Name:Novartis Pharma AG
    Full Title: Phase IIIb study for relapsed/refractory pediatric/young adult acute lymphoblastic leukemia patients to be treated with CTL019
    Medical condition: Paediatric/young adult patients with B-cell acute lymphoblastic leukaemia who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic SCT.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    21.0 100000004864 10063621 Acute lymphoblastic leukaemia recurrent LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) NO (Completed) ES (Completed) BE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001673-14 Sponsor Protocol Number: CCTL019A2205B Start Date*: 2015-10-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
    Medical condition: All patients who have been treated with chimeric antigen receptor (CAR) T-cell therapy in the context of a prior Novartis sponsored or supported study for any indication.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10003917 B-cell type acute leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10003899 B-cell lymphoma PT
    Population Age: Children, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) NO (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) DK (Trial now transitioned) GB (GB - no longer in EU/EEA) SE (Trial now transitioned) FI (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-003205-25 Sponsor Protocol Number: CCTL019B2202 Start Date*: 2016-01-22
    Sponsor Name:Novartis Services Pharma AG
    Full Title: A Phase II, single arm, multicenter trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia
    Medical condition: Paediatric patients with B-cell acute lymphoblastic leukaemia who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic SCT.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    21.0 100000004864 10063621 Acute lymphoblastic leukaemia recurrent LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) NO (Completed) ES (Completed) BE (Completed) Outside EU/EEA IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002849-30 Sponsor Protocol Number: CCTL019B2101J/CHP-959 Start Date*: 2017-11-16
    Sponsor Name:University of Pennsylvania
    Full Title: A Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leuk...
    Medical condition: Chemotherapy resistant or refractory CD19+ B-cell Leukemia and Lymphoma.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10063621 Acute lymphoblastic leukaemia recurrent LLT
    20.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003060-20 Sponsor Protocol Number: CCTL019C2201 Start Date*: 2015-10-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase II, single arm, multicenter trial to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
    Medical condition: Adult patients ≥ 18 years with relapsed or refractory DLBCL, having failed 2 or more lines of therapy and not eligible for HSCT
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10012819 Diffuse large B-cell lymphomas HLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) NO (Completed) NL (Ongoing) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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