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    Summary
    EudraCT Number:2017-004577-14
    Sponsor's Protocol Code Number:Blina-CELL
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2017-004577-14
    A.3Full title of the trial
    Single cycle of blinatumomab followed by high-dose chemotherapy in the induction therapy for Ph-negative acute lymphoblastic leukemia in adults.
    Jeden cyklus blinatumomabu následovaný vysokodávkovanou chemoterapií v indukční léčbě Ph-negativní akutní lymfoblastové leukémie dospělých.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of blinatumomab administered before high-dose chemotherapy in treatment of acute lymphoblastic leukemia in adults.
    Účinnost blinatumomabu podaného před vysokodávkovanou chemoterapií v léčbě akutní lymfoblastové leukémie dospělých.
    A.3.2Name or abbreviated title of the trial where available
    Blina-CELL
    A.4.1Sponsor's protocol code numberBlina-CELL
    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 SponsorÚstav hematologie a krevní transfuze
    B.1.3.4CountryCzech Republic
    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 supportAmgen
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationÚstav hematologie a krevní transfuze
    B.5.2Functional name of contact pointDr. Cyril Šálek
    B.5.3 Address:
    B.5.3.1Street AddressU Nemocnice 2094/1
    B.5.3.2Town/ cityPraha 2
    B.5.3.3Post code128 20
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number420221 977 301
    B.5.6E-mailcyril.salek@uhkt.cz
    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 BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen 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 nameBLINCYTO
    D.3.2Product code AMG103
    D.3.4Pharmaceutical form Powder and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.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, previously untreated, Ph-negative B-precursor acute lymphoblastic leukemia
    Nově diagnostikovaná, dříve neléčená Ph-negativní B-akutní lymfoblastová leukémie
    E.1.1.1Medical condition in easily understood language
    Untreated acute lymphoblastic leukemia
    Neléčená akutní lymfoblastová leukémie
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the percentage of complete molecular responses after two cycles of induction therapy composed of a single cycle of blinatumomab followed by chemotherapy.
    Zhodnotit procento kompletních remisí po dvou cyklech indukční léčby složené z jednoho cyklu blinatumomabu následovaného chemoterapií.
    E.2.2Secondary objectives of the trial
    To evaluate minimal residual disease (MRD) in bone marrow at the end of blinatumomab infusion (Induction cycle I);

    To evaluate progression-free survival (PFS) in patients treated with blinatumomab followed by chemotherapy in the induction therapy;

    To evaluate overall survival (OS) in patients treated with blinatumomab followed by chemotherapy in the induction therapy;

    To determine the percentage of patients undergoing allogeneic stem cell transplantation (alloSCT) due to the suboptimal molecular response after blinatumomab and chemotherapy;

    To evaluate the incidence of infectious complications during induction chemotherapy in patients treated with blinatumomab and chemotherapy;

    To evaluate the incidence and severity of blinatumomab-related adverse events in the induction therapy.
    Zhodnotit minimální reziduální nemoc (MRN) v kostní dřeni po skončení infuze blinatumomabu (na konci Indukce I);
    Zhodnotit přežití bez progrese (PFS) u pacientů léčených v indukci blinatumomabem následovaným chemoterapií;
    Zhodnotit celkové přežití (OS) u pacientů léčených v indukci blinatumomabem následovaným chemoterapií;
    Zhodnotit procento pacientů indikovaných k alogenní trasnplantaci krvetvorných kmenových buněk (aloSCT) z důvodu suboptimální molekulární odpovědi po léčbě blinatumomabem a chemoterapií;
    Zhodnotit výskyt infekčních komplikací v průběhu indukční léčby blinatumomabem následovaným chemoterapií;
    Zhodnotit výskyt a závažnost nežádoucích příhod spojených s podáním blinatumomabu v indukční fázi léčby.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with newly diagnosed, previously untreated, Ph-negative B-precursor acute lymphoblastic leukemia;
    - Age 18-65 years;
    - Lymphoblasts positive for CD19;
    - Eligible to intensive chemotherapy, due to general health status;
    - ECOG performance status ≤2;
    - Diagnostic sample of bone marrow (or peripheral blood with >50% of blasts) available for central MRD assessment;
    - Subject has provided written informed consent prior to any screening procedure.
    - Pacienti s nově diagnostikovanou, dříve neléčenou Ph-negativní B-akutní lymfoblastovou leukémií;
    - Věk 18-65 let;
    - Prokázaná exprese znaku CD19 na lymfoblastech;
    - Celkový zdravotní stav umožňuje podání intenzivní chemoterapie;
    - ECOG výkonnostní stav ≤2;
    - Je k dispozici diagnostický vzorek kostní dřeně (nebo periferní krve s >50 % blastů) pro centrální hodnocení MRN;
    - Pacient před zahájením screeningových procedur podepsal informovaný souhlas s účastí ve studii.
    E.4Principal exclusion criteria
    - History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease;
    - History or presence of central nervous system (CNS) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis;
    - Persisting ALL in the CNS at the end of run-in period; patients with initial cerebrospinal fluid (CSF) infiltration arriving into CSF negativity after up to 4 intrathecal applications of chemotherapy within the first 10 days of therapy are allowed for the study;
    - Current autoimmune disease or history of autoimmune disease with potential CNS involvement;
    - Active known HBV or HCV hepatitis or positive HIV serology;
    - Hypersensitivity to any active substance contained in blinatumomab, including polysorbate 80;
    - Vaccination with a live virus vaccine within 4 weeks prior to the study enrolment;
    - Female patients who are pregnant or breast feeding or patients of childbearing potential not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug;
    - Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study;
    - Any concurrent severe and/or uncontrolled medical condition, which could, in the opinion of the investigator, compromise participation in the study;
    - Concurrent participation in another clinical study with an investigational medical product.
    - Přítomnost jiného zhoubného onemocnění v průběhu posledních 5 let od zahájení protokolem specifikované léčby s výjimkou adekvátně léčených vybraných nádorových onemocnění definovaných v protokolu;
    - Anamnéza nebo přítomnost onemocnění centrálního nervového systému (CNS), konkrétně epilepsie, křečí, paréz, afázie, cévních mozkových příhod, vážných poranění mozku, demence, Parkinsonovy choroby, onemocnění mozečku, organckých duševních poruch a psychotických poruch;
    - Perzistující ALL v CNS na konci run-in periody; pacienti se vstupní leukemickou infiltraci mozkomíšního moku (CSF), kteří dosáhnou CSF negativity po ≤4 intrathekálních podání chemoterapie v průběhu prvních 10 dnů léčby, mohou být do studie zařazeni;
    - Aktivní autoimunitní onemocnění nebo anamnéza autoimunitního onemocnění s rizikem postižení CNS;
    - Známá aktivní infekce virem hepatitidy B a C nebo pozitivita serologického testu na infekci HIV;
    - Hypersenzitivita na jakoukoliv aktivní substanci obsaženou v testovaném přípravku blinatumomabu, včetně polysorbátu 80;
    - Očkování živou vakcínou v průběhu 4 týdnů před zahájením klinického hodnocení;
    - Těhotné nebo kojící ženy nebo pacientky ve fertilním věku, které odmítají dvojí antikoncepci po dobu trvání studie a 3 měsíce po podání poslední dávky studijního léčiva;
    - Muži, jejichž sexuální partnerky jsou ve fertilním věku, kteří odmítají dvojí antikoncepci po dobu trvání studie, z nichž jednou musí být kondom;
    - Souběžná účast v klinickém hodnocení s jiným výzkumným léčivým přípravkem.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Defined as a proportion of patients reaching the complete molecular response after two cycles of induction therapy. Molecular response will be monitored by a patient-specific Ig/TCR rearrangements in an assay with the sensitivity of at least 10e-04.
    Účinnost je definována jako procento pacientů, kteří dosáhli kompletní molekulární odpovědi po dvou indukčních cyklech léčby. Molekulární odpověď bude hodnoceno pomocí specifických přestaveb genů pro imunoglobuliny a T-buněčné receptory (Ig/TCR). Požadovaná minimální citlivost testů je 10e-4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After two cycles of induction therapy, at Week 11.
    Po dvou indukčních cyklech léčby, v týdnu 11.
    E.5.2Secondary end point(s)
    Safety: All AEs will be collected and assessed using the NCI Common Terminology Criteria for Adverse Events, version 4.03.
    Bezpečnost: Zaznamenávány budou všechny nežádoucí příhody. Jejich závažnost bude hodnocena pomocí NCI Common Terminology kritérií, verze 4.03.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 24 months (cumulatively)
    Po 24 týdnech (souhrnně)
    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 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.8.3 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 concerned5
    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 No
    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
    The last visit of the last subject undergoing the trial.
    Poslední studijní návštěva posledního subjektu účastnícího se studie.4
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 5
    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.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)
    Allogeneic Hematopoietic Stem Cell Transplantation
    Alogenní trasnplantace krvetvorných kmenových buněk
    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 Decision2018-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-27
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