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    Summary
    EudraCT Number:2008-005687-13
    Sponsor's Protocol Code Number:R-BMDGELTAMO08
    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:2009-03-05
    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 number2008-005687-13
    A.3Full title of the trial
    Estudio Fase II abierto prospectivo no aleatorizado para valorar la combinación de rituximab, bendamustina, mitoxantrone, dexametasona (R-BMD) en pacientes con Linfoma Folicular refractarios o en recaída
    A.4.1Sponsor's protocol code numberR-BMDGELTAMO08
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGELTAMO (Grupo Español de Linfoma y Transplante Autólogo de Médula Ósea)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name RIBOMUSTIN
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma Pharmaceuticals S.L.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBendamustina
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBendamustina
    D.3.9.1CAS number 3543-75-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeLa bendamustina es un agente alquilante híbrido con propiedades de análogo de las purinas y de alquilante
    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
    Linfoma Folicular refractarios o en recaída
    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
    Evaluar la eficacia del esquema rituximab, bendamustina, mitoxantrone, dexametasona (R-BMD) en términos de respuesta completa y respuesta completa no confirmada.
    E.2.2Secondary objectives of the trial
    · Evaluar la toxicidad asociada al esquema R-BMD
    · Evaluar el papel del mantenimiento con rituximab en prolongar la respuesta y retrasar el retratamiento
    · Evaluar la supervivencia global, la Supervivencia Libre de progresión y supervivencia libre de
    enfermedad y duración de la respuesta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Edad mayor o igual a 18 y menor o igual a 75 años.
    2. Pacientes con Linfoma folicular grado 1, 2 o 3a, CD20+, histológicamente confirmado mediante biopsia de ganglio o tejido. Se aceptará el diagnóstico en médula ósea si no presenta adenopatías accesibles y si se ha descartado LLC y LNH del manto.
    3. Pacientes con Linfoma folicular tratados previamente, refractarios a una primera línea (se excluye Radioterapia) o recidiva tras haber alcanzado cualquier respuesta con tratamiento previo.
    4. ECOG menor o igual a 2.
    5. Firma consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Sospecha clínica o documentación histológica e transformación.
    2. Haber recibido el esquema de quimioterapia previo sin Rituximab.
    3. Trasplante autólogo o alogénico previo.
    4. Infiltración del SNC por LF (Linfoma primario del SNC o meningitis linfomatosa).
    5. Hepatitis B pasada o activa (al menos uno de los siguientes marcadores AgHBs, AgHbe, antiHBc, HBV, DNA)..
    6. Infección VHC. Infección VIH u otras condiciones de inmunopresión grave.
    7. Neoplasias previas excepto cáncer cutáneo no melanoma o de cuello uterino adecuadamente tratado.
    8. Función cardiaca en cardiópata conocida o tratamiento previo con antraciclinas con FE < 50%.
    9. Alteración de la función renal (creatinina > 1,5 x Límite Superior de la Normalidad, LSN) o aclaramiento de creatinina < de 50 ml/h, no relacionada con el linfoma.
    10. Alteración de la función hepática (bilirrubina, GOT/GPT o GGT > 2 x LSN) no relacionada con el linfoma.
    11. Mujeres en periodo de lactancia o embarazadas. Las mujeres potencialmente fértiles se incluirán previo test de embarazo en suero/orina negativo. Utilizarán un método anticonceptivo eficaz que se mantendrá durante 1 año tras finalizar el rituximab.
    12. Pacientes con enfermedades cardiacas, pulmonares, neurológicas, psiquiátricas o metabólicas graves y no secundarias a Linfoma.
    13. Infección grave aguda o crónica en actividad.
    14. Cualquier otra comorbilidad médica o psicológica coexistente que pueda dificultar la participación en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Se aplicarán los criterios del International Workshop to Standardize Response Criteria for NHL (Seminario Internacional para la Normalización de los Criterios de Respuesta para el LNH (Criteria for evaluation of response in Non-Hodgkins Lymphoma, criterios para la evaluación de la respuesta en el linfoma no Hodgkin, Cheson, 1999, Anexo H).

    8.a.1 Respuesta completa (RC)

    1. Desaparición completa de la masa tumoral detectada mediante las técnicas radiológicas diagnósticas aplicadas, con desaparición de síntomas constitucionales o relacionados con afectación directa por el tumor, y normalización de los parámetros bioquímicos anormales (LDH).
    2. Reducción de todos los ganglios linfáticos y masas ganglionares a un tamaño menor o igual a 1,5 cm en su diámetro transverso mayor, en aquellos casos con adenopatías > 1,5 cm al diagnóstico, o menor o igual a 1 cm en aquellos casos con tamaño de 1,1 a 1,5 cm al diagnóstico.
    3. Desaparición de esplenomegalia clínica y radiológica, así como otros órganos aumentados al diagnóstico.
    4. Aspirado-biopsia de médula ósea normal sobre la base de criterios morfológicos de celularidad normal en aspirado con < 30% linfocitos y ausencia de infiltración linfocitaria en médula ósea); la muestra de biopsia debe ser adecuada (> 2 cm).

    8.a.2 Respuesta completa no confirmada (RCnc)

    Se incluyen aquellos casos que reúnen los criterios 1 y 3, pero que además presentan algunos de los rasgos siguientes:
    1. Linfadenopatía aislada o conglomerado adenopático mayor o igual a 1,5 cm en su diámetro transverso mayor que ha reducido su tamaño original en más de un 75%.
    2. Incremento en el número o tamaño de nódulos linfoides en médula ósea sin alteraciones morfológicas o estructurales evidentes (médula ósea indeterminada).

    8.a.3 Respuesta parcial (RP)

    1. Reducción mayor o igual a 50% de las masas correspondientes a las 6 áreas linfoides mayores.
    2. No aumentos de áreas ganglionares ausentes al diagnóstico o aparición de nuevas masas tumorales.
    3. Reducción mayor o igual a 50% de nódulos o masas hepáticas y esplénicas.
    4. La afectación de otros órganos se considera evaluable pero no medible a menos que se realice biopsia de los mismos; la valoración de la médula ósea se considera irrelevante para la determinación de RP porque se considera evaluable pero no medible.

    8.a.4 Enfermedad estable (EE)

    Se define como obtención de respuesta menor a la respuesta parcial, pero sin progresión de la enfermedad.
    8.a.5 Enfermedad progresiva (en RP o EE)
    Incremento > 50% en la suma de los productos de los diámetros mayores de las adenopatías afectas en casos etiquetados de RP o aparición de nuevas lesiones durante o al final del tratamiento.

    8.a.6 Recidiva (en RC o RCnc)

    1. Aparición de nuevas lesiones o incremento mayor o igual a 50% de las lesiones anteriores.
    2. Incremento mayor o igual a 50% del diámetro mayor de cualquiera de las masas anteriores que midiesen mayor o igual a 1 cm.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned40
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state60
    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 Decision2009-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
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