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    Summary
    EudraCT Number:2015-001088-38
    Sponsor's Protocol Code Number:BAY80-6946/17833
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-11-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-001088-38
    A.3Full title of the trial
    A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin?s lymphoma (iNHL) - CHRONOS-4
    Ensayo fase III, aleatorizado, doble ciego, controlado con placebo, multicéntrico del inhibidor PI3K intravenoso Copanlisib en combinación con inmunoquimioterapia estándar versus inmunoquimioterapia estándar en pacientes con linfoma no Hodgkin indolente tras recaída - CHRONOS-4
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relapsed indolent non-Hodgkin's lymphoma.
    Evaluar si copanlisib en combinación con tratamiento estándar es superior al tratamiento estándar solo, para comprobar si copanlisib mejora la respuesta estándar al tratamiento en en pacientes con linfoma no Hodgkin indolente tras recaída.
    A.3.2Name or abbreviated title of the trial where available
    Phase III study of copanlisib with standard immunochemotherapy in relapsed iNHL
    Ensayo fase III de copanlisib con inmunoquimioterapia standard tras recaída en iLNH
    A.4.1Sponsor's protocol code numberBAY80-6946/17833
    A.5.4Other Identifiers
    Name:Pi3K InhibitorNumber:BAY80-6946
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clin. Trials Contact CTP Team
    B.5.3 Address:
    B.5.3.1Street AddressBayer Pharma AG, S102, Level 2, Room 156
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900102372
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCopanlisib
    D.3.2Product code BAY84-1236
    D.3.4Pharmaceutical form Lyophilisate for solution 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 INNCopanlisib
    D.3.9.2Current sponsor codeBAY 84-1236
    D.3.9.3Other descriptive nameBAY 80-6946 (AS DIHYDROCHLORID BAY 84-1236)
    D.3.9.4EV Substance CodeSUB32033
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with relapsed indolent non-Hodgkin's lymphoma
    Pacientes con linfoma indolente no Hodgkin tras recaída.
    E.1.1.1Medical condition in easily understood language
    Relapsed indolent non-Hodgkin's lymphoma
    Linfoma no Hodgkin indolente tras recaída
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10029600
    E.1.2Term Non-Hodgkin's 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
    Safety run-in part
    Primary objective is to determine:
    The recommended phase III dose (RP3D) of copanlisib in combination with standard immunochemotherapy (rituximab and bendamustine [RB] or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone [R-CHOP]) to be used in the subsequent phase III part of the study

    Phase III part (randomized, controlled trial)
    Primary objective is:
    To evaluate whether copanlisib in combination with standard immunochemotherapy, is superior to standard immunochemotherapy in prolonging progression-free survival (PFS), in patients with relapsed indolent non-Hodgkin?s lymphoma, who have received one or more lines of treatment, including rituximab and alkylating agents, and for whom the combination of rituximab with either bendamustine or CHOP represents a valid therapeutic option
    Fase de pre inclusión de seguridad
    Objetivo principal es determinar:
    La dosis recomendada para la fase III (DRF3) de copanlisib en combinación con inmunoquimioterapia estándar (rituximab y bendamustina [R-B] o rituximab, ciclofosfamida, doxorubicina, vincristina y prednisona [R-CHOP]) que se utilizará en la parte de la fase III subsiguiente del estudio.

    Parte de la fase III (ensayo controlado y aleatorizado)
    El objetivo principal es evaluar:
    Si copanlisib en combinación con inmunoquimioterapia estándar es superior a la inmunoquimioterapia estándar en la prolongación de la supervivencia libre de progresión (SLP), en pacientes con linfoma no Hodgkin indolente tras recaída, que han recibido una o más líneas de tratamiento, incluidos rituximab y agentes alquilantes, y para quienes la combinación de rituximab con bendamustina o CHOP representa una opción terapéutica válida
    E.2.2Secondary objectives of the trial
    Safety run-in part
    The secondary objectives are to evaluate (for patients that stay on treatment after Cycle 1):
    Radiological and clinical indicators of treatment efficacy
    Safety and tolerability of copanlisib in combination with R-B/R-CHOP

    Phase III part (randomized, controlled trial)
    Secondary objectives are to evaluate:
    Other radiological and clinical indicators of treatment efficacy (objective response rate (ORR), duration of response (DOR), complete response rate (CRR), time to progression (TTP), time to next antilymphoma treatment (TTNT), overall survival (OS, 5 year survival rate), time to improvement and the time to deterioration in diseaserelated symptoms - physical)
    Safety and tolerability of copanlisib in combination with R-B/R-CHOP
    Fase de pre inclusión de seguridad
    Los objetivos secundaros son evaluar (para paciente que están en tratamiento tras el Ciclo 1):
    Indicadores radiológicos y clínicos de la eficacia del tratamiento
    Seguridad y tolerabilidad de copanlisib en combinación con R-B/R-CHOP

    Parte de la fase III (ensayo controlado y aleatorizado)
    Los objetivos secundaros son evaluar:
    Otros indicadores radiológicos y clínicos de la eficacia del tratamiento [tasa de respuesta objetiva (TRO), duración de la respuesta (DR), tasa de respuesta completa (TRC), tiempo transcurrido hasta la progresión (THP), tiempo transcurrido hasta el siguiente tratamiento para el linfoma (THST), supervivencia global (SG, tasa de supervivencia a los 5 años), tiempo transcurrido hasta la mejoría y el tiempo transcurrido hasta el empeoramiento de los síntomas relacionados con la enfermedad, físicos (SRE-F)]
    Seguridad y tolerabilidad de copanlisib en combinación con R-B/R-CHOP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main criteria for inclusion:
    - Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
    o Follicular lymphoma (FL) G1, G2, or G3a
    o Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5x109/L at the time of diagnosis and at study entry
    o Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM)
    o Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
    - Patients must have relapsed after at least 1 prior line of therapy, including rituximab and alkylating agents. A previous regimen is defined as one of the following: at least 2 months of single-agent therapy; at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K inhibitors is acceptable provided there is no resistance (treatment stopped for other reasons than progressive disease).
    - Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification.
    - Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ? 2 x upper limit of normal.
    - Male or female patients >= 18 years of age.
    - Eastern Cooperative Oncology Group (ECOG) performance status ? 2.
    - Life expectancy of at least 3 months.
    - Availability of fresh tumor tissue and/or archival tumor tissue at Screening.
    - Adequate baseline laboratory values as assessed within 7 days before starting study treatment.
    - Left ventricular ejection fraction >= 50%.
    -Principales criterios de inclusión:
    Diagnóstico histológico confirmado de LNH indolente CD20 positivo con subtipo histológico limitado a:
    oLinfoma folicular (LF) G1, G2, o G3a
    oLinfoma de linfocitos pequeños con un recuento absoluto de linfocitos < 5 × 109/l en el momento del diagnóstico y en el momento de la inclusión
    oLinfoma linfoplasmocítico / macroglobulinemia de Waldenström (LLP/MW)
    oLinfoma de la zona marginal (LZM) (esplénico, ganglionar o extraganglionar)
    -Los pacientes deben haber presentado recaída después de un mínimo de 1 línea de tratamiento anterior, que incluyera rituximab y agentes alquilantes. Un tratamiento previo se define por uno de los siguientes supuestos: un mínimo de 2 meses de tratamiento con un único agente; un mínimo de 2 ciclos consecutivos de poliquimioterapia; trasplante autólogo; radioinmunoterapia. Se aceptará la exposición previa a inhibidores de la PI3K siempre que no haya resistencia (suspensión del tratamiento por motivos distintos a progresión de la enfermedad).
    -Los pacientes sin MW deben tener al menos una lesión medible bidimensionalmente (que no debe haber sido irradiada previamente), de acuerdo con la clasificación de Lugano.
    -Los pacientes con MW que no tengan al menos una lesión medible bidimensionalmente en la evaluación radiológica basal deben presentar enfermedad medible, definida por la presencia de la paraproteína inmunoglobulina M (IgM), con un nivel máximo de IgM mayor o igual a 2 veces el límite superior de la normalidad.
    -Pacientes de ambos sexos mayor o igual a 18 años.
    -Estado funcional del ECOG (Eastern Cooperative Oncology Group) menor o igual a 2.
    -Esperanza de vida mínima de 3 meses.
    -Disponibilidad de tejido tumoral fresco y/o tejido tumoral de archivo en el momento de la selección.
    -Valores analíticos basales aceptables, según evaluación en los 7 días previos al inicio del tratamiento del estudio.
    -Fracción de eyección ventricular izquierda mayor o igual a 50 %.
    E.4Principal exclusion criteria
    Main criteria for exclusion:
    - Histologically confirmed diagnosis of follicular lymphoma (FL) grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
    - Rituximab resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last course of treatment with a rituximab containing regimen).
    - Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at Screening.
    - History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator).
    - Known lymphomatous involvement of the central nervous system.
    - Human immunodeficiency virus (HIV) infection.
    - Hepatitis B (HBV) and C (HCV) infection. Patients with serologic markers of HBV immunization due to vaccination (HBsAg negative, Anti-HBc negative and Anti-HBs positive) will be eligible.
    - Congestive heart failure > New York Heart Association (NYHA) class 2.
    - Uncontrolled hypertension (systolic blood pressure > 150 mmHg or
    diastolic pressure > 90 mmHg despite optimal medical management).
    Criterios principales de exclusión:
    -Diagnóstico confirmado histológicamente de linfoma folicular (LF) de grado 3b o enfermedad con transformación, o leucemia linfocítica crónica. En los pacientes con sospecha clínica de transformación de la enfermedad, se recomienda una biopsia de tejido fresco.
    -Resistencia a rituximab en cualquier línea de tratamiento (definiéndose la resistencia como ausencia de respuesta o progresión en los 6 meses posteriores al último ciclo de un tratamiento que contenga rituximab).
    -Diabetes mellitus de tipo I o II con HbA1c > 8,5 % o glucemia plasmática en ayunas > 160 mg/dl en la selección.
    -Antecedentes o presencia de enfermedad pulmonar intersticial o deterioro grave de la función pulmonar (según el criterio del investigador).
    -Diagnóstico de afectación linfomatosa del sistema nervioso central.
    -Infección por el virus de la inmunodeficiencia humana (VIH).
    -Infección por los virus de la hepatitis B (VHB) y de la hepatitis C (VHC). Serán elegibles los pacientes con marcadores serológicos de inmunización frente al VHB debido a vacunación (HBsAg negativo, anti-HBc negativo y anti-HB positivo).
    -Insuficiencia cardíaca congestiva de clase > II de la New York Heart Association (NHYA).
    -Hipertensión no controlada (presión arterial sistólica > 150 mm Hg o presión arterial diastólica > 90 mm Hg a pesar del tratamiento médico óptimo).
    E.5 End points
    E.5.1Primary end point(s)
    The primary completion event for this study is PFS (progression assessed by central review or death from any cause if death occurs before progression). The analysis will be performed when approximately 273 PFS events in FL patients occur.
    El criterio principal de valoración del ensayo es la SLP (progresión basada en revisión central o muerte si la muerte ocurre antes de la progresión). El análisis se realizará cuando se llegue a 273 acontecimientos de SLP en LF
    E.5.1.1Timepoint(s) of evaluation of this end point
    The analysis will be performed when approximately 273 PFS events in FL patients occur.
    El análisis se realizará cuando se llegue a 273 acontecimientos de SLP en LF
    E.5.2Secondary end point(s)
    Secondary efficacy variables are objective response rate (ORR), duration of response (DOR), complete response rate (CRR), time to progression (TTP), time to next anti-lymphoma treatment (TTNT), overall survival (OS, 5 year survival rate), time to improvement and the time to deterioration in disease-related symptoms - physical (disease-related symptoms - physical (DRS-P)) of at least 3 points of lymphoma as measured by the FLymSI-18 questionnaire (FLymSI = NCCN-FACT Lymphoma Symptom Index).
    Secondary efficacy variables are objective response rate (ORR), duration of response (DOR), complete response rate (CRR), time to progression (TTP), time to next anti-lymphoma treatment (TTNT), overall survival (OS, 5 year survival rate), time to improvement and the time to deterioration in disease-related symptoms - physical (disease-related symptoms - physical (DRS-P)) of at least 3 points of lymphoma as measured by the FLymSI-18 questionnaire (FLymSI = NCCN-FACT Lymphoma Symptom Index).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The analysis will be performed when approximately 273 PFS events in FL patients occur.
    El análisis se realizará cuando se llegue a 273 acontecimientos de SLP en LF
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Luxembourg
    Mexico
    New Zealand
    Philippines
    Poland
    Portugal
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLP
    Ultimo paciante última visita
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 700
    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
    Ninguno
    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 Decision2016-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-11-10
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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
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