Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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   43874   clinical trials with a EudraCT protocol, of which   7293   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
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-002773-19
    Sponsor's Protocol Code Number:INCB39110-206
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-13
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002773-19
    A.3Full title of the trial
    An Open-Label Phase 1/2 Study of INCB039110 in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Studio di fase 1/2 in aperto su INCB039110 in combinazione con ibrutinib in soggetti affetti da linfoma diffuso a grandi cellule B recidivante o refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the impact of Itacitinib when added to Ibrutinib for the treatment of relapsed or refractory diffuse large B-Cell lymphoma
    Studio di fase 1/2 in aperto su INCB039110 in combinazione con ibrutinib in soggetti affetti da linfoma diffuso a grandi cellule B recidivante o refrattario
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberINCB39110-206
    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 SponsorINCYTE CORPORATION
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number0
    B.5.5Fax number0013024252734
    B.5.6E-mailRA@incyte.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/OD/169/17
    D.3 Description of the IMP
    D.3.1Product nameITACITINIB
    D.3.2Product code INCB039110
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNITACITINIB ADIPATE
    D.3.9.1CAS number 1334302-63-4
    D.3.9.2Current sponsor codeINCB039110 ADIPATE
    D.3.9.4EV Substance CodeSUB184194
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 IMBRUVICA - 140 MG -CAPSULE RIGIDE -USO ORALE - FLACONE (HDPE) - 1 FLACONE (120 CAPSULE RIGIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/14/1264, EU/3/13/1115, EU/3/12/984
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBRUTINIB
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    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 diffuse large B-cell lymphoma
    Linfoma diffuso a grandi cellule B recidivante o refrattario
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory diffuse large B-cell lymphoma (cancer of B cells, a type of white blood cell)
    Linfoma diffuso a grandi cellule B diffuso o refrattario (cancro delle cellule B, un tipo di globuli bianchi)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012821
    E.1.2Term Diffuse large B-cell lymphoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of Phase 1 is to evaluate the safety and tolerability of INCB039110 in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
    The primary objective of Phase 2 is to evaluate the efficacy of INCB039110 in combination with ibrutinib in subjects with relapsed or refractory non-GCB DLBCL as demonstrated by ORR.
    L¿obiettivo primario della fase 1 ¿ valutare la sicurezza e la tollerabilit¿ di INCB039110 in combinazione con ibrutinib in soggetti affetti da linfoma diffuso a grandi cellule B recidivante o refrattario. L¿obiettivo primario della fase 2 ¿ valutare l¿efficacia di INCB039110 in combinazione con ibrutinib in soggetti affetti da non-GCB DLBCL, come dimostrato dall¿ORR.
    E.2.2Secondary objectives of the trial
    The secondary objective of Phase 1 is to evaluate the efficacy of INCB039110 in combination with ibrutinib in terms of objective response rate (ORR).
    The secondary objectives of Phase 2 are as follows:
    ¿ To evaluate efficacy in terms of duration of response (DOR), durable response rate, progression-free survival (PFS), and overall survival (OS).
    ¿ To evaluate the safety and tolerability of the treatment combination.
    L¿obiettivo secondario della fase 1 ¿ valutare l¿efficacia di INCB039110 in combinazione con ibrutinib in termini di tasso di risposta obiettiva (ORR).
    Gli obiettivi secondari della fase 2 dello studio sono i seguenti:
    ¿ Valutare l¿efficacia in termini di durata della risposta (Duration Of Response, DOR), tasso di risposta duratura, sopravvivenza libera da progressione (Progression-Free Survival, PFS) e sopravvivenza globale (Overall Survival, OS).
    ¿ Valutare la sicurezza e la tollerabilit¿ del trattamento di combinazione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female, 18 years or older.
    • Histologically documented diagnosis of DLBCL.
    - For Phase 1, subjects may have any DLBCL subtype.
    - For Phase 2, subjects must have ABC or unclassifiable subtypes of DLBCL confirmed by immunohistochemistry using the Hans algorithm.
    - Relapsed or refractory DLBCL, defined as having received at least 1 but no more than 3 prior treatment regimens and ineligible for high-dose chemotherapy/autologous stem cell transplant
    - Fluorodeoxyglucose-avid disease (based on local evaluation) per the Lugano Classification. Fluorodeoxyglucose-avid disease is defined as disease with a 5-point scale score of 4 or 5.
    - Pazienti di sesso maschile o femminile di età pari o superiore a 18 anni.
    - Diagnosi di DLBCL documentato istologicamente:
    Per la fase 1 i soggetti possono essere affetti da qualsiasi sottotipo di DLBCL.
    Per la fase 2 i soggetti devono essere affetti da DLBCL di sottotipo ABC o non classificabile, confermato da immunoistochimica utilizzando l’algoritmo di Hans.
    - DLBCL recidivante o refrattario, definito come aver ricevuto almeno 1 ma non più di 3 precedenti regimi di trattamento e non idoneità alla chemioterapia ad alto dosaggio/al trapianto autologo di cellule staminali.
    - Malattia avida di fluorodeossiglucosio (in base alla valutazione locale) secondo la classificazione di Lugano. La malattia avida di fluorodeossiglucosio è definita come malattia con un punteggio di 4 o 5 della scala a 5 punti.
    E.4Principal exclusion criteria
    • Transformed DLBCL or DLBCL with coexistent histologies (eg, follicular or mucosa-associated lymphoid tissue lymphoma).
    • Primary mediastinal (thymic) large B-cell lymphoma.
    • Known central nervous system lymphoma (either primary or metastatic).
    • Autologous stem cell transplant within the previous 3 months, allogeneic stem cell transplant within the previous 6 months, or active graft versus host disease following allogeneic transplant.
    • DLBCL trasformato o DLBCL con istologie coesistenti (ad es., linfoma del tessuto linfoide associato alle mucose o follicolare).
    • Linfoma a grandi cellule B primitivo del mediastino (timico).
    • Linfoma del sistema nervoso centrale noto (primitivo o metastatico).
    • Trapianto autologo di cellule staminali nei 3 mesi precedenti, trapianto allogenico di cellule staminali nei 6 mesi precedenti o reazione immunitaria contro l'ospite dopo trapianto allogenico.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 : Safety and tolerability will be assessed by evaluating the frequency, duration, and severity of AEs (including serious adverse events [SAEs] and dose-limiting toxicities [DLTs]), and changes in clinical and laboratory assessments.
    Phase 2 : Efficacy will be assessed by ORR, defined as the percentage of subjects achieving either a CR or PR.
    Fase 1: la sicurezza e la tollerabilità saranno valutate valutando la frequenza, la durata e la gravità degli eventi avversi (compresi eventi avversi gravi [SAE] e tossicità dose-limitanti [DLT]) e cambiamenti nelle valutazioni cliniche e di laboratorio.
    Fase 2: l'efficacia sarà valutata mediante ORR, definita come la percentuale di soggetti che ottengono una CR o una PR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1: Adverse events will be monitored from the time the subject signs the ICF through the safety follow-up. A DLT will be defined as the occurrence of any toxicities occurring up to and including Day 28. Phase 2 : Week 8, Week 16, and every 16 weeks thereafter until disease progression.
    Fase 1: gli eventi avversi saranno monitorati dal momento in cui il soggetto firma l'ICF attraverso il follow-up di sicurezza. Una DLT sarà definita come il verificarsi di eventuali tossicità che si verificano fino al Giorno 28.
    Fase 2: Settimana 8, Settimana 16 e ogni 16 settimane successive fino alla progressione della malattia.
    E.5.2Secondary end point(s)
    Phase 1 : Efficacy will be assessed by ORR, defined as the percentage of subjects achieving either a complete response (CR) or partial response (PR).
    Phase 2:
    ¿ DOR, defined as the time from earliest date of disease response until earliest date of disease progression.
    ¿ Durable response rate, defined as the percentage of subjects achieving a CR or PR for > 16 weeks.
    ¿ PFS, defined as the time from enrollment until the earliest date of disease progression determined by objective radiographic disease assessments, or death due to any cause.
    ¿ OS, defined as the date of enrollment until death due to any cause.
    ¿ Safety and tolerability via assessment of the frequency, duration, and severity of AEs and SAEs, and changes in clinical and laboratory assessments.
    L¿efficacia sar¿ valutata mediante l¿ORR, definito come la percentuale di soggetti che raggiungono o una risposta completa (Complete Response, CR) o una risposta parziale (Partial Response, PR).
    Fase 2:
    - DOR, definita come il tempo trascorso dalla prima data di risposta della malattia alla prima data di progressione della malattia.
    ¿ Tasso di risposta duratura, definito come la percentuale di soggetti che raggiungono una CR o una PR per >16 settimane.
    ¿ PFS, definita come il tempo trascorso dall¿arruolamento fino alla prima data di progressione della malattia, determinata mediante valutazioni radiologiche obiettive della malattia, oppure fino al decesso per qualunque causa.
    ¿ OS, definita come il tempo trascorso dalla data dell¿arruolamento al decesso per qualunque causa.
    ¿ Sicurezza e tollerabilit¿ mediante la valutazione della frequenza, della durata e della gravit¿ degli AE e dei SAE e le modifiche delle valutazioni cliniche e di laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events will be monitored from the time the subject signs the ICF through the safety follow-up.
    Efficacy endpoints: Week 8, Week 16, and every 16 weeks thereafter until disease progression.
    Gli eventi avversi saranno monitorati dal momento in cui il soggetto firma l'ICF attraverso il follow-up di sicurezza.
    Endpoint di efficacia: settimana 8, settimana 16 e ogni 16 settimane successive fino alla progressione della malattia.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Evaluate the safety and tolerability of INCB039110 in combination with ibrutinib
    Valutare al sicurezza e la tollerabilit¿ di INCB039110 in combinazione con Ibrutinib.
    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.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Belgium
    France
    Italy
    Netherlands
    United Kingdom
    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
    The end of Phase 1 will occur when all subjects have completed the DLT surveillance period; Phase 2 will end once the last subject is assessed for response.
    La fine della fase 1 si verifica quando tutti i soggetti hanno completato il periodo di sorveglianza DLT; La fase 2 terminer¿ una volta valutato l'ultimo soggetto per la risposta.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days5
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 78
    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.
    Nessuno.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Thu May 09 01:38:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA