Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Axicabtagene ciloleucel

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    8 result(s) found for: Axicabtagene ciloleucel. Displaying page 1 of 1.
    EudraCT Number: 2017-002261-22 Sponsor Protocol Number: KTE-C19-107 Start Date*: 2018-09-11
    Sponsor Name:Kite Pharma, Inc.
    Full Title: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
    Medical condition: Relapsed/Refractory Diffuse Large B cell Lymphoma (r/r DLBCL).
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012822 Diffuse large B-cell lymphoma refractory PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Completed) BE (Completed) IT (Completed) ES (Ongoing) FR (Completed) SE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001912-13 Sponsor Protocol Number: KTE-C19-105 Start Date*: 2018-04-24
    Sponsor Name:Kite Pharma, Inc.
    Full Title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) (ZUMA-5)
    Medical condition: Relapsed or Refractory Indolent Non-Hodgkin Lymphoma (r/r) iNHL.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065856 Non-Hodgkin's lymphoma unspecified histology indolent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002291-13 Sponsor Protocol Number: KTE-C19-112 Start Date*: 2020-02-07
    Sponsor Name:Kite Pharma, Inc
    Full Title: A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma (ZUMA-12)
    Medical condition: Adult subjects with high-risk large B-cell lymphoma, including either high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 translocations (double-hit or triple-hit lymphomas) or Internat...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10012819 Diffuse large B-cell lymphomas HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-003260-28 Sponsor Protocol Number: KT-US-473-0133 Start Date*: 2022-07-18
    Sponsor Name:Kite Pharma, Inc.
    Full Title: A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma
    Medical condition: Relapsed and/or Refractory Follicular Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    24.1 100000004851 10085262 Follicular lymphomas HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001868-28 Sponsor Protocol Number: ALYCANTE Start Date*: 2020-12-31
    Sponsor Name:LYSARC
    Full Title: Phase 2, Open-Label Study evaluating Axi-Cel as a 2nd line therapy in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to Autologous Stem Cell Transplantation
    Medical condition: relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) who are ineligible to Autologous Stem Cell Transplantation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10003899 B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005007-86 Sponsor Protocol Number: KTE-C19-101 Start Date*: 2016-12-15
    Sponsor Name:Kite Pharma, Inc.
    Full Title: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE C19 in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL) (ZUMA-1)
    Medical condition: Diffuse Large B-cell Lymphoma (DLBCL), Primary Mediastinal B cell lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10036711 Primary mediastinal large B-cell lymphomas HLT
    20.0 100000004851 10012819 Diffuse large B-cell lymphomas HLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing) DE (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-000937-15 Sponsor Protocol Number: HO161 Start Date*: 2022-08-25
    Sponsor Name:UMCG
    Full Title: A phase II non-inferiority design study comparing point-of-care produced CAR T-cell to commercial CAR T-cells in patients with relapsed/refractory Non-Hodgkin Lymphoma
    Medical condition: B-Cell Non Hodgkin Lymphoma
    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: Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005843-21 Sponsor Protocol Number: KT-US-982-5968 Start Date*: 2022-02-08
    Sponsor Name:KITE PHARMA INC.
    Full Title: Long-term Follow-up Study for Participants of Kite Sponsored Interventional Studies Treated With Gene-Modified Cells
    Medical condition: B-cell malignancies and Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10026801 Mantle cell lymphoma refractory PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008977 Chronic lymphocytic leukemia recurrent LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008978 Chronic lymphocytic leukemia refractory LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065856 Non-Hodgkin's lymphoma unspecified histology indolent PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012822 Diffuse large B-cell lymphoma refractory PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060558 Acute myeloid leukemia recurrent LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10081514 Acute myeloid leukemia refractory LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10063621 Acute lymphoblastic leukaemia recurrent LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006599 Burkitt's lymphoma refractory PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036714 Primary mediastinal large B-cell lymphoma refractory PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) FR (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 07 14:19:58 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA