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    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).

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    Summary
    EudraCT Number:2020-001868-28
    Sponsor's Protocol Code Number:ALYCANTE
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-07-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-001868-28
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating the effectiveness of Axi-Cel in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to Autologous Stem Cell Transplantation
    A.4.1Sponsor's protocol code numberALYCANTE
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLYSARC
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKite Pharma
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressCHU Lyon Sud - bâtiment 2D
    B.5.3.2Town/ cityPierre Bénite cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number33472669333
    B.5.5Fax number33426074055
    B.5.6E-mailalycante@lysarc.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name YESCARTA
    D.2.1.1.2Name of the Marketing Authorisation holderKite Pharma EU B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1393
    D.3 Description of the IMP
    D.3.1Product nameaxicabtagene ciloleucel
    D.3.2Product code axicabtagene ciloleucel
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaxicabtagene ciloleucel
    D.3.9.3Other descriptive nameAxicabtagene ciloleucel
    D.3.9.4EV Substance CodeSUB188282
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.4 to 2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberGene therapy medicinal product. Doc. Ref. EMA/CAT/360525/2015
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) who are ineligible to Autologous Stem Cell Transplantation
    E.1.1.1Medical condition in easily understood language
    relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) who are ineligible to Autologous Stem Cell Transplantation
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003899
    E.1.2Term B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the complete metabolic response (CMR) at 3 months from Axi-cel infusion (without additional anticancer therapy) based on investigator disease assessment
    E.2.2Secondary objectives of the trial
    To evaluate efficacy and safety of Axi-cel infusion (without additional anticancer therapy) with respect to secondary efficacy endpoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed written Informed Consent Form
    2.Patient who understands and speaks one of the country official languages
    3.Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), follicular lymphoma Grade 3B per WHO 2016 classification and Primary mediastinal B-cell lymphomas. Indolent B-NHL who transformed into aggressive B-NHL and were previously treated with R-CHOP are eligible.
    4.Tumoral tissue (at diagnosis or relapse) available for central pathology review, exploratory endpoints and ancillary studies
    5.Positron-emission tomography (PET)-positive disease
    6.Patients must have received adequate first-line therapy including at a minimum:
    o An anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and
    o CHOP or CHOP-like chemotherapy
    Note: CHOP-like chemotherapy corresponds to ACVBP or EPOCH or COPADEM. Dose-reduced CHOP (i.e. miniCHOP) is excluded except for dose-reductions of vincristin due to peripheral neuropathy. Patients who have received additional drugs in combination with CHOP or CHOP-like regimen are eligible.
    7.Relapsed or refractory disease after first-line chemoimmunotherapy (full dose of R-CHOP or R-CHOP-like regimen), documented by PET-scan:
    o Relapsed disease defined as complete remission to first-line therapy followed by biopsy proven disease relapse within 12 months from end of first-line therapy.
    Patients who received first line of R-CHOP or obinutuzumab-CHOP for an indolent B-NHL who relapse as transformed aggressive B-NHL within a year from the end of first-line therapy are eligible.
    o Refractory disease defined as:
    - Progressive disease (PD) during first-line therapy
    - Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g. 4 cycles of R-CHOP)
    - Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease
    8. At least 2 weeks must have elapsed since any prior systemic cancer therapy at the time the patient provides consent
    9. Patients must be Autologous Stem Cell Transplantation (ASCT)-ineligible as defined by:
    o Patient deemed ineligible for high-dose chemotherapy and ASCT based on physician’s assessment
    o AND at least one of the following criteria:
    - Age ≥ 65 years or
    - Age ≥ 18 years and Hematopoietic Cell Transplantation-specific Comorbidity Index (HCT-CI – Appendix 09) score ≥3 or
    - Age ≥ 18 years and prior ASCT (as 1st line consolidation)
    10. Patients must meet CAR-T-eligible as defined by:
    o Patient deemed eligible for CAR T-cells therapy by the CAR-T physician
    o AND all the following criteria:
    - ECOG performance status of 0, 1 or 2
    - Adequate vascular access for leukapheresis procedure (either peripheral or central venous line)
    - Absolute neutrophil count (ANC) ≥ 1 G/L
    - Platelets ≥ 75 G/L
    - Absolute lymphocyte count ≥ 0,1 G/L
    - Creatinine clearance (as estimated by Cockcroft Gault or MDRD) ≥ 40 mL/min
    - Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5xULN
    - Total bilirubin ≤ 26 µmol/L, except in patients with Gilbert’s syndrome
    - Cardiac ejection fraction ≥ 45%
    - Baseline oxygen saturation ≥ 92% on room air
    11. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential)
    E.4Principal exclusion criteria
    1. Patients who received more than one prior line of systemic therapy
    2. Patients who are intolerant to first-line therapy or who received suboptimal first-line therapy, including dose-reduced R-CHOP (“R-miniCHOP”), and those who discontinued prematurely first-line therapy due to toxicity are not eligible (except for dose-reductions or discontinuation of vincristin due to peripheral neuropathy)
    3. Prior CD19 targeted therapy
    4. Patients with cardiac atrial or cardiac ventricular lymphoma involvement
    5. Requirement for urgent therapy due to tumor mass effects, such as bowel obstruction or blood vessel compression
    6. Patient with clinically significant pleural effusion
    7. History of another primary malignancy that has not been in remission for at least 2 years (except for nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast)). A maintenance treatment is not allowed.
    8. Patients with detectable Central Nervous System (CNS) lymphoma. Patients with a history of CNS lymphoma but no active CNS disease (after systematic MRI and lumbar puncture) at the time of enrollment will be eligible.
    9. History or presence of non-malignant CNS disorder, such as seizure disorder requiring anti-convulsive therapy, cerebellar disease, or any autoimmune disease with CNS involvement disease
    10. Active hepatitis B or hepatitis C infection at the time of screening
    Active Hepatitis B Virus (HBV) infection defined as:
    - HBs Ag positive
    - HBs Ag negative, anti-HBs antibody positive and/or anti-HBc antibody positive with detectable viral DNA
    11. Positive serology of human immunodeficiency virus (HIV) at the time of screening
    12. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or Axi-cel administration
    13. History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
    14. History of autoimmune disease requiring systemic immunosuppression and/or systemic disease modifying agents within the last year
    15. History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed.
    16. History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
    17. History of severe immediate hypersensitivity reaction attributed to aminoglycosides
    18. Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the course of the study
    19. Women of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of chemotherapy on the fetus or infant. Patients of either sex who are not willing to practice birth control from the time of consent and at least 6 months after the last dose of Axi-cel
    20. In the investigator’s judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
    21. Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
    E.5 End points
    E.5.1Primary end point(s)
    CMR at 3 months based on investigator disease assessment according to PET-scan using the Lugano Response Criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 3 months from Axi-cel infusion (without additional anticancer therapy) based on investigator disease assessment (INV).
    E.5.2Secondary end point(s)
    • CMR at 3 months from Axi-cel infusion (without additional anticancer therapy) determined by central imaging review (using the Lugano Response Criteria)
    • Event-free survival (EFS) at 3, 6 and 12 months from leukapheresis based on investigator disease assessment. EFS is defined as the time between leukapheresis and :
    o any event preventing Axi-cel infusion if Axi-cel is never infused, or
    o death, disease progression, or instauration of a new lymphoma therapy for lymphoma progression after Axi-cel infusion.
    • EFS at 3, 6 and 12 months from leukapheresis based on central imaging review. EFS is defined as the time between leukapheresis and :
    o any event preventing Axi-cel infusion if Axi-cel is never infused, or
    o death, disease progression, or instauration of a new lymphoma therapy for lymphoma progression after Axi-cel infusion.
    • Modified EFS (mEFS) at 6 and 12 months from leukapheresis based on investigator assessment and central imaging review. mEFS is defined as the time between leukapheresis and :
    o any event preventing Axi-cel infusion if Axi-cel is never infused, or
    o death, disease progression, or instauration of a new lymphoma therapy for lymphoma progression after Axi-cel infusion or failure to achieve a CMR at 6 and 12 months post-CAR infusion.
    • Best objective response (complete and partial metabolic response)
    • Duration of response (DOR)
    • Progression-free survival (PFS) from Axi-cel infusion
    • Overall survival (OS) from leukaphaeresis and Axi-cel infusion
    • DOR, PFS, OS at 2 years and 3 years
    • Safety of Axi-cel
    • Health-related Quality of life (EORTC QLQ-C30, EQ-5D-5L and QLQ-NHL-HG29)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Complete Metabolic response (CMR) response at 3 months from Axi-cel infusion
    • Event-free survival (EFS) at 3, 6 and 12 months from leukapheresis
    • Modified EFS (mEFS) at 6 and 12 months leukapheresis
    • Best objective response (CMR and PMR) : Evaluation at D14, M1, M3, M6 and M12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation LYSA
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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