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    Summary
    EudraCT Number:2020-005591-35
    Sponsor's Protocol Code Number:INCMOR0208-101
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2021-09-01
    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 number2020-005591-35
    A.3Full title of the trial
    A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti-CD19 Monoclonal Antibody Tafasitamab and the PI3K delta Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia (topMIND)
    Estudio Fase 1b/2a, tipo Basket, para evaluar la Seguridad, Tolerabilidad, Farmacocinética y Eficacia de la terapia en combinación de Tafasitamab, anticuerpo monoclonal anti-CD19, y Parsaclisib (Inhibidor PI3Kδ), en Pacientes Adultos con Linfoma No-Hodgkin o Leucemia Linfocítica Crónica en Recaída o Refractario (topMIND)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tafasitamab and Parsaclisib in Adult Participants With Relapsed/Refractory Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
    Estudio Fase 1b/2a para evaluar la Seguridad, Tolerabilidad, Farmacocinética y Eficacia de Tafasitamab y Parsaclisib en Pacientes Adultos con Linfoma No-Hodgkin o Leucemia Linfocítica Crónica en Recaída o Refractario
    A.3.2Name or abbreviated title of the trial where available
    topMIND
    A.4.1Sponsor's protocol code numberINCMOR0208-101
    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, Delaware
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number+13024986700
    B.5.5Fax number+13024252734
    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 numberEU/3/14/1424
    D.3 Description of the IMP
    D.3.1Product nametafasitamab
    D.3.2Product code INCMOR0208
    D.3.4Pharmaceutical form Powder for concentrate 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 INNTAFASITAMAB
    D.3.9.1CAS number 1422527-84-1
    D.3.9.2Current sponsor codeINCMOR0208
    D.3.9.3Other descriptive nameMOR208
    D.3.9.4EV Substance CodeSUB197699
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Yes
    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 Yes
    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 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 numberEU/3/19/1285
    D.3 Description of the IMP
    D.3.1Product nameparsaclisib 20 mg Tablet
    D.3.2Product code INCB050465 20 mg tablet
    D.3.4Pharmaceutical form 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 INNPARSACLISIB
    D.3.9.1CAS number 1426698-88-5
    D.3.9.2Current sponsor codeINCB050465
    D.3.9.3Other descriptive nameparsaclisib hydrochloride
    D.3.9.4EV Substance CodeSUB193468
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 3
    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 numberEU/3/19/1285
    D.3 Description of the IMP
    D.3.1Product nameparsaclisib 5 mg Tablet
    D.3.2Product code INCB050465 5 mg tablet
    D.3.4Pharmaceutical form 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 INNPARSACLISIB
    D.3.9.1CAS number 1426698-88-5
    D.3.9.2Current sponsor codeINCB050465
    D.3.9.3Other descriptive nameparsaclisib hydrochloride
    D.3.9.4EV Substance CodeSUB193468
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 4
    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 numberEU/3/19/1285
    D.3 Description of the IMP
    D.3.1Product nameparsaclisib 2.5 mg Tablet
    D.3.2Product code INCB050465 2.5 mg tablet
    D.3.4Pharmaceutical form 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 INNPARSACLISIB
    D.3.9.1CAS number 1426698-88-5
    D.3.9.2Current sponsor codeINCB050465
    D.3.9.3Other descriptive nameparsaclisib hydrochloride
    D.3.9.4EV Substance CodeSUB193468
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.IMP: 5
    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 numberEU/3/19/1285
    D.3 Description of the IMP
    D.3.1Product nameparsaclisib 1 mg Tablet
    D.3.2Product code INCB050465 1 mg tablet
    D.3.4Pharmaceutical form 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 INNPARSACLISIB
    D.3.9.1CAS number 1426698-88-5
    D.3.9.2Current sponsor codeINCB050465
    D.3.9.3Other descriptive nameparsaclisib hydrochloride
    D.3.9.4EV Substance CodeSUB193468
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
    Linfoma No-Hodgkin o Leucemia Linfocítica Crónica
    E.1.1.1Medical condition in easily understood language
    Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
    Linfoma No-Hodgkin o Leucemia Linfocítica Crónica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10009310
    E.1.2Term CLL
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10076596
    E.1.2Term Marginal zone lymphoma
    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 LLT
    E.1.2Classification code 10012883
    E.1.2Term Diffuse lymphoma
    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 24.0
    E.1.2Level LLT
    E.1.2Classification code 10080213
    E.1.2Term In situ follicular lymphoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10026801
    E.1.2Term Mantle 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 10026800
    E.1.2Term Mantle 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
    * Dose confirmation period (Phase 1b):
    To determine the safety, tolerability, and DLTs of combination therapy with tafasitamab + parsaclisib in participants with R/R NHL or CLL who have been previously treated with at least 2 prior lines of systemic anti-lymphoma therapy.

    * Dose expansion period (Phase 2a):
    To assess the preliminary efficacy of combination therapy with tafasitamab + parsaclisib in participants with R/R NHL or CLL who have been previously treated with at least 2 prior lines of systemic anti-lymphoma therapy.
    * Periodo de confirmación de la dosis (fase Ib): Determinar la seguridad, la tolerabilidad y las TLD del tratamiento combinado con tafasitamab + parsaclisib en participantes con LNH o LLC R/R que hayan sido tratados previamente con al menos 2 líneas previas de tratamiento sistémico contra el linfoma.

    * Periodo de expansión de la dosis (fase IIa): Evaluar la eficacia preliminar del tratamiento combinado con tafasitamab + parsaclisib en participantes con LNH o LLC R/R que hayan sido
    tratados previamente con al menos 2 líneas previas de tratamiento sistémico contra el linfoma.
    E.2.2Secondary objectives of the trial
    To estimate the PK of tafasitamab when given as combination therapy with parsaclisib
    Estimar la FC de tafasitamab cuando se administra como tratamiento combinado con parsaclisib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Men and women aged > or = 18 years at the time of consent.

    * Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures.

    * Histologically confirmed R/R B-cell malignancy of the following types:
    a. Cohort 1: DLBCL not otherwise specified, T-cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr virus–positive DLBCL of the elderly, Grade 3b FL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma), histological transformation from an earlier diagnosis of low-grade lymphoma (such as FL, MZL, CLL) into DLBCL
    b. Cohort 2: MCL with documentation of either overexpression of cyclin D1 or t(11;14)
    c. Cohort 3: FL Grade 1, 2, and 3a
    d. Cohort 4: MZL, including extranodal, nodal, and splenic subtypes
    e. Cohort 5: CLL or SLL

    * Received at least 2 prior systemic treatment regimens as follows:
    a. Cohorts 1 and 2 (DLBCL, MCL): Must have been previously treated with at least 1 prior chemoimmunotherapy regimen that included an anti-CD20 antibody. This includes treatments such as chemotherapy plus rituximab or obinutuzumab, with or without rituximab or obinutuzumab maintenance. Note: At least 6 doses of anti-CD20 chemoimmunotherapy must have been given in prior therapy.
    b. Cohorts 3 and 4 (FL, MZL): Must have been previously treated with at least 1 prior chemoimmunotherapy or immunotherapy regimen that included an anti-CD20 antibody. This includes treatments such as rituximab or obinutuzumab monotherapy or chemotherapy plus rituximab or obinutuzumab, with or without rituximab or obinutuzumab maintenance. Note: At least 6 doses of anti-CD20 immunotherapy must have been given in prior therapy.
    c. Cohort 5 (CLL/SLL): Must have been previously treated with at least 1 prior systemic therapy including a BTK inhibitor regimen or chemoimmunotherapy regimen that included an anti-CD20 antibody.

    * Relapsed, progressive, or refractory NHL or CLL:
    a. Relapsed: PD after response of CR to prior therapy.
    b. Progressive: PD after response of PR or stable disease to prior therapy.
    c. Refractory: achieved less than PR to the last prior therapy, or achieved a CR or PR that lasted < 6 months before PD.
    * Hombres y mujeres de 18 años o más en el momento del consentimiento.

    * Capacidad para comprender y disposición para firmar un FCI por escrito y cumplir con todas las visitas y los procedimientos del estudio.

    * Neoplasia maligna de linfocitos B R/R confirmada mediante histología de los siguientes tipos:
    a. Cohorte 1: LDCBG sin especificar, linfoma de linfocitos B grandes rico en linfocitos T/histiocitos, LDCBG positivo para el virus de Epstein-Barr en pacientes de edad avanzada, LF de grado 3b, linfoma de linfocitos B de alto grado con reordenaciones de MYC y BCL2 y/o BCL6 (linfoma doble hit o triple hit), transformación histológica de un diagnóstico temprano de linfoma de bajo grado
    (como LF, LZM, LLC) a LDCBG
    b. Cohorte 2: LCM con documentación de sobreexpresión de la ciclina D1 o t(11;14)
    c. Cohorte 3: LF de grado 1, 2 y 3a
    d. Cohorte 4: LZM, incluidos los subtipos extraganglionar, ganglionar y esplénico
    e. Cohorte 5: LLC o LLCP

    * Haber recibido al menos 2 pautas de tratamiento sistémico previas según las siguientes pautas:
    a. Cohortes 1 y 2 (LDCBG, LCM): debe haber sido tratado previamente con al menos 1 pauta previa de quimioinmunoterapia que incluyera un anticuerpo anti-CD20. Esto incluye tratamientos como quimioterapia más rituximab u obinutuzumab, con o sin mantenimiento con rituximab u obinutuzumab. Nota: Se deben haber administrado al menos 6 dosis de quimioinmunoterapia anti-CD20 en el tratamiento previo.
    b. Cohortes 3 y 4 (LF, LZM): debe haber sido tratado previamente con al menos 1 pauta previa de quimioinmunoterapia o inmunoterapia que incluyera un anticuerpo anti-CD20. Esto incluye tratamientos como rituximab u obinutuzumab en monoterapia o quimioterapia más rituximab u obinutuzumab, con o sin mantenimiento con rituximab u obinutuzumab. Nota: Se deben haber administrado al menos 6 dosis de inmunoterapia anti-CD20 en el tratamiento previo.
    c. Cohorte 5 (LLC/LLCP): debe haber sido tratado previamente con al menos 1 tratamiento sistémico previo, incluyendo una pauta con un inhibidor de BTK o una pauta de quimioinmunoterapia que incluyeran un anticuerpo anti-CD20.

    * LNH o LLC recidivante, progresivo o resistente:
    a. Recidivante: PE después de una respuesta de RC al tratamiento previo.
    b. Progresivo: PE tras una respuesta de RP o enfermedad estable al tratamiento previo.
    c. Resistente: se ha logrado una respuesta que no alcanza la categoría de RP al último tratamiento previo o se ha logrado una RC o RP con una duración de menos de 6 meses antes de la PE.
    E.4Principal exclusion criteria
    * Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, for example, primary mediastinal B-cell lymphoma, Burkitt lymphoma, B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (gray zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; intravascular B cell lymphoma.

    * History of or evidence of CNS lymphoma (primary and secondary).

    * Any anticancer and/or investigational therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization) within 30 days or 5 half-lives (whichever is greater) prior to the first dose of study treatment (C1D1).

    * Inadequate recovery (> Grade 1) from toxicity and/or complications from a major surgery before C1D1.
    * Cualquier otro tipo histológico de linfoma según la clasificación de la OMS de 2016 de neoplasias linfoides, por ejemplo, linfoma mediastínico de linfocitos B primario, linfoma de Burkitt, linfoma de linfocitos B inclasificable, con características intermedias entre el LDCBG y el linfoma de Hodgkin clásico (linfoma de la zona gris); linfoma primario de cavidades; LDCBG cutáneo primario tipo pierna; linfoma de linfocitos B intravascular.

    * Antecedentes o indicios de linfoma del SNC (primario y secundario).

    * Cualquier tratamiento antineoplásico y/o en investigación (p. ej., quimioterapia, radioterapia, cirugía, inmunoterapia, terapia biológica, hormonoterapia o embolización tumoral) en los 30 días o las 5 semividas (lo que sea mayor) anteriores a la primera dosis del tratamiento del estudio (D1C1).

    * Recuperación inadecuada (grado >1) de toxicidad y/o complicaciones de una cirugía mayor antes del D1C1.
    E.5 End points
    E.5.1Primary end point(s)
    * Dose confirmation period (Phase 1b):
    Incidence and severity of TEAEs and incidence of DLTs.

    * Dose expansion period (Phase 2a):
    ORR, defined as the percentage of participants having best response of CR/CMR or PR/PMR per investigator assessment.
    * Periodo de confirmación de la dosis (fase Ib): Incidencia e intensidad de los AAST e incidencia de las TLD.
    * Periodo de expansión de la dosis (fase IIa): TRG, definida como el porcentaje de participantes con una mejor respuesta de RC/RMC o RP/RMP
    según la evaluación del investigador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    * Dose confirmation period (Phase 1b): after 1 cycle (28 days)

    * Dose expansion period (Phase 2a): ORR will be analyzed when all subjects in the respective cohort have received at least 1 post-baseline disease assessment or have progressed, withdrawn from the study, or died
    * Periodo de confirmación de la dosis (fase Ib): después del ciclo 1 (28 días)
    * Periodo de expansión de la dosis (fase IIa): la TRG se analizará cuando todos los pacientes en su cohorte hayan tenido al menos 1 evaluación de la enfermedad posterior a la basal o hayan progresado, abandonado el estudio o muerto
    E.5.2Secondary end point(s)
    PK parameters of tafasitamab when given in combination with parsaclisib.
    Ctrough (ie, predose), Cmax, tmax, Cmin, and AUCt will be summarized by descriptive statistics.
    Parámetros FC de tafasitamab cuando se administra en combinación con parsaclisib. La C valle (es decir, antes de la dosis), la C máx , el t máx , la C mín y el ABC t se resumirán mediante estadísticas descriptivas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout the study
    A lo largo del estudio
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.7.1Other trial design description
    estudio tipo basket
    basket study
    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 trial5
    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 concerned9
    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 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
    United States
    France
    Germany
    Italy
    Spain
    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
    LPLV
    Última visita del último pacientes
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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)
    Participants who are receiving long-term benefit may be transferred to a company-sponsored rollover study after completion of this study
    Los pacientes que se beneficien a largo plazo podrían pasar a otro estudio del promotor tras completar el presente ensayo
    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 Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-25
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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