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    Summary
    EudraCT Number:2016-003778-42
    Sponsor's Protocol Code Number:CC-122-DLBCL-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-003778-42
    A.3Full title of the trial
    A Phase 1/2 Open-label, Multicenter Study of CC-122 in Combination With R-CHOP-21 for Previously Untreated Poor-Risk (IPI ≥ 3) Diffuse Large B-Cell Lymphoma
    Estudio de fase 1/2, abierto y multicéntrico de CC-122 en combinación con R-CHOP-21 para el linfoma difuso de células B grandes con riesgo desfavorable (IPI ≥ 3) no tratado previamente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to determine how the drug CC-122 works in the body and how safe it is in combination with R-CHOP for previously untreated poor-risk Diffuse Large B-Cell Lymphoma
    Estudio clínico para determinar como la medicación CC-122 actúa en el cuerpo y como de seguro es en combinación con R-CHOP para el linfoma difuso de células B grandes con riesgo desfavorable no tratado
    A.4.1Sponsor's protocol code numberCC-122-DLBCL-002
    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 SponsorCelgene 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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+3491422-9000
    B.5.5Fax number+1913266-0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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/3/16/1672
    D.3 Description of the IMP
    D.3.1Product nameCC-122
    D.3.2Product code CC-122
    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 INNCC-122
    D.3.9.2Current sponsor codeCC-122
    D.3.9.3Other descriptive nameCC-122 formulated capsule F6
    D.3.9.4EV Substance CodeSUB179455
    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.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/3/16/1672
    D.3 Description of the IMP
    D.3.1Product nameCC-122
    D.3.2Product code CC-122
    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 INNCC-122
    D.3.9.2Current sponsor codeCC-122
    D.3.9.3Other descriptive nameCC-122 formulated capsule F6
    D.3.9.4EV Substance CodeSUB179455
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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/3/16/1672
    D.3 Description of the IMP
    D.3.1Product nameCC-122
    D.3.2Product code CC-122
    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 INNCC-122
    D.3.9.2Current sponsor codeCC-122
    D.3.9.3Other descriptive nameCC-122 formulated capsule F6
    D.3.9.4EV Substance CodeSUB179455
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Previously untreated, high-intermediate and high-risk (International Prognostic Index [IPI] ≥ 3) diffuse large B-cell lymphoma (DLBCL).
    Linfoma difuso de células B grandes (LDCBG) con riesgo intermedio alto y alto (Índice pronóstico internacional [IPI] ≥ 3) no tratado previamente.
    E.1.1.1Medical condition in easily understood language
    Previously untreated, with poor-risk diffuse large B-cell lymphoma (DLBCL).
    Linfoma difuso de células B grandes (LDCBG) con riesgo desfavorable no tratado previamente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - The primary objective of the Phase 1 portion of the study is to evaluate the safety and tolerability of CC-122 in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy and the anti-CD20 monoclonal antibody rituximab (R CHOP) given in 21-day treatment cycles (R-CHOP-21) for first-line treatment of patients with poor-risk (IPI ≥3) DLBCL in order to identify an appropriate dose and schedule for further investigation in Phase 2

    - The primary objective of the Phase 2 portion of the study is to evaluate the rate of complete response when adding CC-122 to the standard R-CHOP-21 regimen in first-line treatment of patients with poor-risk DLBCL.
    El objetivo principal de la parte de fase 1 del estudio es evaluar la seguridad y tolerabilidad de CC-122 en combinación con quimioterapia con ciclofosfamida, doxorubicina, vincristina y prednisona (CHOP) y el anticuerpo monoclonal anti-CD20 rituximab (R CHOP) administrados en ciclos de tratamiento de 21 días (R-CHOP-21) para el tratamiento en primera línea en pacientes con LDCBG con riesgo desfavorable (IPI ≥ 3), con el fin de identificar una dosis y una pauta adecuadas para la investigación posterior en la fase 2.
    El objetivo principal de la parte de fase 2 del estudio es evaluar la tasa de respuesta completa cuando se añade CC-122 a la pauta R-CHOP-21 habitual en el tratamiento en primera línea en pacientes con LDCBG con riesgo desfavorable.
    E.2.2Secondary objectives of the trial
    - The secondary objective in Phase 1 is to evaluate early signals of efficacy

    - The secondary objectives in Phase 2 are :

    To characterize additional efficacy parameters such as progression-free survival (PFS) and overall survival (OS)

    To further describe the safety and tolerability associated with CC-122 in combination with R-CHOP-21 in this setting

    To evaluate biomarkers which are predictive of clinical response to CC-122, when administered in combination with R-CHOP-21
    El objetivo secundario de la fase 1 es evaluar las señales iniciales de eficacia
    Los objetivos secundarios de la fase 2 son:
    - Caracterizar parámetros adicionales de eficacia como la supervivencia libre de progresión (SSP) y la supervivencia global (SG).
    - Describir mejor la seguridad y tolerabilidad asociadas a la CC-122 en combinación con R CHOP-21 en este contexto
    - Evaluar biomarcadores predictivos de la respuesta clínica a CC-122 cuando se administra en combinación con R-CHOP-21
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
    2.Subject has documented, histologically locally confirmed, previously untreated CD20+ DLBCL (NOS) per World Health Organization (WHO) classifications
    3.Subject has poor-risk disease defined as International Prognostic Index (IPI) score ≥ 3 (high-intermediate or high-risk classification)
    1.Edad mínima de 18 años en el momento de firmar el documento de consentimiento informado (DCI).
    2.Presentar LDCBG (NOS) CD20+ documentado, histológica y localmente confirmado, no tratado previamente, según las clasificaciones de la Organización Mundial de la Salud (OMS)
    3. Tener enfermedad con riesgo desfavorable definido por una puntuación del Índice pronóstico internacional (IPI) ≥ 3 (clasificación de riesgo intermedio alto o alto).
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from enrollment:
    1.Subject is seropositive for or has active viral infection with hepatitis B virus (HBV)
    2.Subject is known to be seropositive for, or have an active infection with, hepatitis C virus (HCV)
    3.Subject is known to be seropositive for, or have an active infection with, human immunodeficiency virus (HIV)
    4.Subject has any neuropathy > Grade 1
    5.Subject has impaired cardiac function or clinically significant cardiac diseases
    6.Subject has confirmed central nervous system (CNS) involvement by DLBCL
    La presencia de cualquiera de los criterios siguientes excluirán al paciente de participar en el estudio:
    1.El sujeto es seropositivo para el virus de la hepatitis B (VHB) o presenta una infección viral activa por el VHB
    2. Se sabe que el sujeto es seropositivo para el virus de la hepatitis C (VHC) o presenta una infección activa por el virus
    3. Se sabe que el sujeto es seropositivo para el virus de la inmunodeficiencia humana (VIH) o presenta una infección activa por el virus.
    4. El sujeto presenta neuropatía de grado > 1.
    5. El sujeto tiene disfunción cardiaca o cardiopatías clínicamente importantes
    6. El sujeto presenta afectación del sistema nervioso central (SNC) por el LDCBG confirmada
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1: Maximum Tolerated Dose/Maximum Administered Dose (MTD/MAD)
    Phase 2: Complete Response Rate (CRR)
    Fase 1: Dosis máxima tolerada/dosis administrada máxima (DMT/DAM)
    Fase 2: Tasa de respuesta completa (TRC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Treatment
    Finalización de tratamiento
    E.5.2Secondary end point(s)
    -Objective Response Rate (ORR)
    -ORR by Predictive Gene Signature
    -Progression-free Survival (PFS)
    -Event-free Survival (EFS)
    -Overall Survival
    -Safety
    - Tasa de respuesta objetiva (TRO)
    - TRO según la carga génica predictiva
    - Supervivencia sin progresión (SSP)
    - Supervivencia sin episodios (SSE)
    - Supervivencia global
    - Seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints will be measured throughout the treatment and up to 24 months as applicable (please refer to table 4 in the protocol)
    Los objetivos se medirán durante todo el tratamiento y hasta 24 meses según corresponda (consulte la tabla 4 del protocolo)
    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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Belgium
    Canada
    Spain
    United States
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analyses, as prespecified in the protocol, whichever is the later date.
    La finalización del estudio se define tanto como la fecha de la última visita del último paciente que completa la visita de seguimiento posterior a la terminación del tratamiento ó bien la fecha en la que se recibe el último dato del último paciente requerido para los análisis primarios, secundarios y exploratorios, tal y como se específica en el protocolo, lo que ocurra antes.
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 49
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 82
    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)
    After completing or discontinuing from planned study treatment, all subjects without disease progression, start of a new disease therapy, or withdrawal of consent from the entire study, will be followed for periodic efficacy assessments, information about new disease therapies and survival status. Patients will go back to the standard care therapy.
    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 Decision2017-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-16
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