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    Summary
    EudraCT Number:2015-001151-68
    Sponsor's Protocol Code Number:TUD-APOLLO-064
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-02
    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 number2015-001151-68
    A.3Full title of the trial
    A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia
    Estudio aleatorizado de fase III para comparar el trióxido de arsénico (ATO) combinado con ATRA e idarubicina frente a quimioterapia estándar basada en ATRA y antraciclinas (AIDA) en pacientes con leucemia promielocítica aguda de alto riesgo de nuevo diagnostico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia
    Estudio aleatorizado de fase III para comparar el trióxido de arsénico (ATO) combinado con ATRA e idarubicina frente a quimioterapia estándar basada en ATRA y antraciclinas (AIDA) en pacientes con leucemia promielocítica aguda de alto riesgo de nuevo diagnostico
    A.3.2Name or abbreviated title of the trial where available
    APOLLO
    A.4.1Sponsor's protocol code numberTUD-APOLLO-064
    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 SponsorFUNDACION PETHEMA
    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 supportFUNDACION PETHEMA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSTART FROM SCRACTH S.L.
    B.5.2Functional name of contact pointELENA
    B.5.3 Address:
    B.5.3.1Street AddressCALLE FERNAN GONZALEZ 28, 4ºF
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28009
    B.5.3.4CountrySpain
    B.5.4Telephone number0034627524002
    B.5.6E-maileniembro@sfscro.com
    B.Sponsor: 2
    B.1.1Name of SponsorTechnische Universitt Dresden
    B.1.3.4CountryGermany
    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 supportTeva Pharmaceuticals Europe B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBundesministerium fr Bildung und Forschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Fakultt der TU Dresden, Medizinische Klinik und Poliklinik I
    B.5.2Functional name of contact pointcoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstrae 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number00493514582583
    B.5.5Fax number00493514584367
    B.5.6E-mailuwe.platzbecker@uniklinikum-dresden.de
    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 Trisenox (R)
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA Pharmaceuticals Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameArsenic trioxide (ATO)
    D.3.4Pharmaceutical form 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 INNArsenic trioxid
    D.3.9.1CAS number 1327-53-3
    D.3.9.2Current sponsor codeATO
    D.3.9.3Other descriptive nameARSENIC TRIOXIDE
    D.3.9.4EV Substance CodeSUB12467MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    newly diagnosed high-risk acute promyelocytic leukemia (APL)
    Pacientes con leucemia promielocítica aguda de alto riesgo de nuevo diagnóstico (LPA/LMA M3)
    E.1.1.1Medical condition in easily understood language
    newly diagnosed high-risk acute promyelocytic leukemia (APL)
    Pacientes con leucemia promielocítica aguda de alto riesgo de nuevo diagnóstico (LPA/LMA M3)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001019
    E.1.2Term Acute promyelocytic leukaemia
    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
    To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen) in newly diagnosed high-risk APL
    Comparar la supervivencia libre de evento (SLE) del grupo de tratamiento experimental, que incluye ATO/ATRA e idarubicina, con el tratamiento estándar basado en ATRA más quimioterapia (AIDA)
    E.2.2Secondary objectives of the trial
    - complete remission (CR) , overall survival (OS) and cumulative incidence of relapse (CIR) rates
    - cumulative incidence of secondary myelodysplastic syndromes or acute myeloid leukaemia
    - early death during induction
    - quality of life
    - toxicity profile
    - kinetics of MRD
    - duration of in-patient treatment
    - health economics
    - Tasas de RC, SG e IAR
    - Incidencia acumulada de síndrome mielodisplásico (SMD) o LMA secundarios
    - Muerte precoz durante la inducción
    - Calidad de vida
    - Perfil de toxicidad
    - Cinética de la EMR
    - Duración del tratamiento hospitalario
    - Recursos sanitarios
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent
    - women or man with a newly diagnosed APL by cytomorphology, confirmed by molecular analysis
    - Age ≥18 and ≤ 65 years
    - ECOG performance status 0-3
    - WBC at diagnosis > 10 GPt/l
    - serum total bilirubin ≤ 3.0 mg/dl (≤ 51 µmol/l)
    - serum creatinine ≤ 3.0 mg/dl (≤ 260 µmol/l)
    - women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
    o Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml)
    o Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
    o Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device – IUD).
    o Sexual abstinence
    o Vasectomy of the sexual partner
    Consentimiento informado
    - Mujeres u hombres con LPA de nuevo diagnóstico mediante citomorfología, confirmada mediante análisis molecular*
    - Edad ≥18 y ≤ 65 años
    - Grado de actividad según la escala ECOG 0–3
    - Recuento de leucocitos en el momento del diagnóstico > 10x109/l
    - Bilirrubina total en suero ≤ 3,0 mg/dl (≤ 51 µmol/l)
    - Creatinina en suero ≤ 3,0 mg/dl (≤ 260 µmol/l)
    - Las mujeres deben cumplir al menos uno de los siguientes criterios para poder ser incluidas en el ensayo clínico:
    o Posmenopáusicas (12 meses de amenorrea natural o 6 meses de amenorrea con hormona foliculoestimulante (FSH) en suero > 40 U/ml)
    o En periodo posoperatorio (es decir, 6 semanas) tras ovariectomía bilateral con o sin histerectomía
    o Aplicación continua y correcta de un método anticonceptivo con índice de Pearl > 1% (p. ej., implantes, fármacos de efecto prolongado, anticonceptivos orales, dispositivo intrauterino [DIU])
    o Abstinencia sexual
    o Vasectomía del compañero sexual
    E.4Principal exclusion criteria
    - patients who are not eligible for chemotherapy as per discretion of the treating physician
    - APL secondary to previous radio- or chemotherapy for non-APL disease
    - other active malignancy at time of study entry (exception: Basal-Cell Carcinoma)
    - lack of diagnostic confirmation of APL at genetic level
    - Significant arrhythmias, ECG abnormalities
    - other cardiac contraindications for intensive chemotherapy (L-VEF <50%)
    - uncontrolled, life-threatening infections
    - severe non controlled pulmonary or cardiac disease
    - severe hepatic or renal dysfunction
    - HIV and/or active hepatitis C infection
    - pregnant or breast-feeding patients
    - allergy to trial medication or excipients in study medication
    - substance abuse; medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results
    - use of other investigational drugs at the time of enrolment or within 30 days before study entry
    - Pacientes que no sean aptos para recibir quimioterapia a juicio del médico responsable del tratamiento
    - LPA secundaria a radioterapia o quimioterapia anteriores por enfermedad distinta de LPA
    - Otra neoplasia maligna en el momento de la incorporación en el estudio (excepción: carcinoma de células basales)
    - Falta de confirmación del diagnóstico de LPA a nivel genético (*véase más arriba)
    - Arritmias significativas, anomalías en ECG:
    -Síndrome del QT largo congénito
    -Antecedentes o presencia de taquiarritmia ventricular o auricular significativa
    -Bradicardia en reposo clínicamente significativa (< 50 latidos por minuto)
    -QTc > 500 ms en ECG de cribado para ambos sexos (con la fórmula de QTcF que se detalla en la sección 5.5.6)
    -Bloqueo de rama derecha más hemibloqueo anterior izquierdo, bloqueo bifascicular
    - Otras contraindicaciones cardiacas de la quimioterapia intensiva (FEVI < 50%)
    - Infecciones no controladas potencialmente mortales
    - Enfermedad pulmonar o cardiaca grave no controlada
    - Disfunción hepática o renal grave
    - Infección activa por VIH y/o hepatitis
    - Esclerosis múltiple activa (se pueden incluir pacientes con EM inactiva)
    - Pacientes embarazadas o en periodo de lactancia
    - Alergia al medicamento del ensayo clínico o a los excipientes de este
    - Consumo de drogas; afecciones médicas, psicológicas o sociales que puedan interferir con la participación del paciente en el estudio o en la evaluación de los resultados del estudio
    - Consumo de otros fármacos en investigación en el momento de la inclusión o en los 30 días anteriores a la incorporación en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is event-free survival.
    El criterio de valoración principal del estudio es la supervivencia libre de evento
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint of the study is event-free survival. This is a time to event endpoint. This cumulative endpoint includes the following events: no achievement of hematological complete remission after induction therapy; no achievement of molecular remission after the last consolidation course (molecular resistance); relapse (hematological/molecular); death including early death (within 30 days after randomization) or development of secondary myelodysplasia or leukemia.
    El criterio de valoración principal del estudio es la supervivencia libre de evento. Se trata de un criterio de valoración de tiempo hasta el evento. Este criterio de valoración acumulativo incluye los siguientes eventos: no obtención de remisión hematológica completa tras el tratamiento de inducción; no obtención de remisión molecular tras el último ciclo de consolidación (grupo A tras 4 ciclos, grupo B tras 3 ciclos) (resistencia molecular); recidiva (hematológica/molecular); muerte, incluida la muerte precoz (en los 30 días siguientes a la aleatorización); o desarrollo de mielodisplasia o leucemia secundaria
    E.5.2Secondary end point(s)
    - complete remission (CR), overall survival (OS) and cumulative incidence of relapse (CIR) rates
    - cumulative incidence of secondary myelodysplastic syndromes or acute myeloid leukaemia
    - early death during induction
    - quality of life
    - toxicity profile
    - kinetics of MRD
    - duration of in-patient treatment
    - health economics
    - Tasa de RC hematológica tras la inducción
    - Tasa de muerte precoz durante la inducción
    - Tasa de supervivencia global (SG) a los 2 años
    - Tasa de incidencia acumulada de SMD o LMA secundarios
    - Tasa de incidencia acumulada de recidiva (IAR) a los 2 años
    - Incidencia de toxicidad hematológica y no hematológica
    - Tasa de remisión molecular tras el último ciclo de consolidación
    - Valoración de la reducción del nivel de transcrito PML/RARĪ± durante el tratamiento
    - Evaluación de las diferencias en las siguientes escalas seleccionadas de calidad de vida a priori: función física y cognitiva además de fatiga, náuseas y vómitos, estreñimiento y pérdida de apetito
    - Evaluación de las diferencias en la reconstitución inmunitaria entre los dos grupos
    - Días de hospitalización totales durante el tratamiento e impacto económico sanitario
    E.5.2.1Timepoint(s) of evaluation of this end point
    -whole study
    -todo el 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 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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    standard of care treatment according to European Guidelines
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    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
    LVLS
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 280
    F.1.3Elderly (>=65 years) No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 280
    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 discontinuation of study treatment, patients will pass the end of study visit and survival will further be observed during follow up until end of entire trial. Upon discontinuation from assigned study treatment, subjects may receive additional (non protocol) therapy at the discretion of the treating physician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SAL - Study Alliance Leukemia
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation AMLSG - Deutsch-Österreichische AML Studiengruppe
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation AML CG - München Studiengruppe
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation OSHO - Ostdeutsche Studiengruppe Hämatologie und Onkologie e.V.
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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