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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-003913-32
    Sponsor's Protocol Code Number:HeLeNe-18-02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-003913-32
    A.3Full title of the trial
    Randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare intensive postremission therapy double blinded with or without glasdegib in older patients with newly diagnosed AML


    Randomisierte Phase 3 Studie zum Vergleich zweier Dosierungsschemata von Gemtuzumab Ozogamicin als Zusatz zur Standard-Induktionstherapie sowie doppel-verblindet Glasdegib oder Placebo in Kombination mit Standard-Postremissionstherapie bei älteren, neu an AML erkrankten Patienten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Gemtuzumab Ozogamicin in addition to standard induction therapy and comparison of standard postremission therapy versus standard postremission therapy in combination with Glasdegib in patients with newly diagnosed acute myeloid leukemia.
    A.3.2Name or abbreviated title of the trial where available
    GnG
    A.4.1Sponsor's protocol code numberHeLeNe-18-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04093505
    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 SponsorRuprecht-Karls-University of Heidelberg Medical Faculty represented in law by Heidelberg University Hospital
    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 supportHeidelberg University Hospital
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportPFIZER INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHeidelberg University Hospital
    B.5.2Functional name of contact pointProf. Dr. Richard F. Schlenk
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 130/3
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number496221566228
    B.5.5Fax number496221565863
    B.5.6E-mailrichard.schlenk@nct-heidelberg.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 Mylotarg
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    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 nameGemtuzumab Ozogamicin
    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 INNGEMTUZUMAB OZOGAMICIN
    D.3.9.1CAS number 220578-59-6
    D.3.9.4EV Substance CodeSUB20794
    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: 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlasdegib
    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 IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaurismo
    D.3.9.3Other descriptive nameGLASDEGIB MALEATE
    D.3.9.4EV Substance CodeSUB192378
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlasdegib
    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 IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaurismo
    D.3.9.3Other descriptive nameGLASDEGIB MALEATE
    D.3.9.4EV Substance CodeSUB192378
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute myeloid leukemia (AML)
    E.1.1.1Medical condition in easily understood language
    leukemia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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
    To assess clinical efficacy of sequential or one-dose gemtuzumab ozogamicin as adjunct to induction therapy in older patients with newly diagnosed AML. Clinical efficacy is determined by MRD-negativity after induction therapy.

    To assess clinical efficacy of glasdegib as adjunct to 2 months consolidation and as single agent 6 months maintenance therapy in older patients with newly diagnosed AML. Clinical efficacy is determined by event-free survival (EFS) defined as the time from randomization to time until one of the following events, whichever occurs first: a) failure to obtain complete remission (CR) or complete remission with incomplete hematological recovery (CRi), b) relapse from complete remission for patients with induction success or c) death from any cause. Patients without an applicable event are censored on the last date of follow-up.
    E.2.2Secondary objectives of the trial
    Complete remission rate (CRR) and overall survival (OS).
    Relapse-free survival (RFS), defined as the time from achievement of a CR/CRi after randomization to time of recurrence of the disease or death from any cause, whatever occurs first.
    Assessment of patient reported outcomes.
    Evaluation of safety based on duration of neutropenia and leukopenia, incidence of infection, duration of initial hospitalization.
    Cost-effectiveness analysis of the four different treatment schedules from health care payer´s perspective.
    Budget impact analysis of introducing effective treatment schedule(s) in everyday clinical practice.
    Mapping the EORTC QLQ-C30 cancer specific instrument to the SF-36 generic instrument for older patients with newly diagnosed AML in Germany.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with newly diagnosed CD33 positive acute myeloid leukemia according to the 2016 WHO classification
    • Genetic and immunophenotypic assessment in the central laboratory
    • No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis (≤7 days) *
    • Age ≥60 years, no upper age limit
    • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2. See appendix 19.1
    • Signed written informed consent
    • Ability of patient to understand character and consequences of the clinical trial
    • Non-pregnant and non-nursing women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to start of study treatment. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile.
    • WOCBP must be using an effective method of birth control to avoid pregnancy throughout the study and for 7 months after the last dose of the IMP. This includes effective contraception methods that can achieve a failure rate of less than 1% per year (e.g. hormonal contraceptive and condom, IUD/IUS and condom) or sterilization, resulting in a failure rate less than 1% per year.
    • Fertile men must be willing and able to use an effective method of birth control (i.e. latex condoms) throughout the study for up to 7 months after the last dose of the IMP, if their sexual partners are WOCBP (acceptable methods see above). A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
    E.4Principal exclusion criteria
    • AML with PML-RARA or BCR-ABL1
    • Patients with known active central nervous system (CNS) leukemia (assessed clinically).
    • Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent (HMA) for AML. (treatment of a preceding myelodysplastic syndrome (MDS) with HMA is not an exclusion criterion.)
    • Inadequate renal function: creatinine >1.5 x upper normal serum level; estimated creatinine clearance ≤30 mL/min (calculated using the standard method for the institution).
    • Inadequate liver function: ALT and AST ≥2.5 x ULN), total bilirubin ≥1.5 x ULN; Alkaline phosphatase ≥2.5 x ULN. Known liver cirrhosis or history of sinusoidal obstruction syndrome (SOS), also known as hepatic veno-occlusive disease (VOD)
    • Uncontrolled hypertension; severe obstructive or restrictive ventilation disorder
    • Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF NYHA III/IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms
    • QTc interval >470 msec using the Fridericia correction (QTcF).
    • Uncontrolled infection
    • Patients known to be refractory to platelet or packed red cell transfusions as per institutional guidelines, or who are known to refuse or who are likely to refuse blood product support.
    • Patients with a “currently active” second malignancy other than non-melanoma skin cancer. Patients are not considered to have a “currently active” malignancy if they have completed therapy for more than one year and are considered by their physician to be at less than 30% risk of relapse within one year.
    • Severe neurologic or psychiatric disorder interfering with ability of giving informed consent
    • Known or suspected active alcohol or drug abuse
    • Known positivity for human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV), or hepatitis A infection
    • Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
    • No consent for biobanking and for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
    • Pregnancy and lactation
    • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
    • Participation in a clinical study involving an investigational drug(s) (Phases 1-4) within 4 weeks prior to study entry.
    E.5 End points
    E.5.1Primary end point(s)
    For the gemtuzumab ozogamicin primary objective, the primary estimand according to the ICH-E9 (R1) [40] addendum is defined as:
    Treatment: GO-147 (experimental arm) compared to GO-1 (control arm)
    Population: all patients fulfilling the in- and exclusion criteria
    Variable: MRD-negativity (MRD) defined as absence of leukemic cells at the end of the induction therapy assessed by flow-cytometry.
    Post-randomisation events: if MRD-negativity cannot be measured, the outcome will be imputed (hypothetical strategy; see also Section 10.5.3), the outcome of patients who drop out of the study before MRD measurement will be imputed (hypothetical strategy; see also Section 10.5.3), changes in treatment, or discontinuation of treatment will be ignored (treatment policy strategy), any-cause death before MRD measurement will be regarded as MRD-positive (composite strategy).
    Summary measure: Odds ratio for the endpoint MRD-negativity between the two treatment arms

    For the glasdegib primary objective, the primary estimand is defined as:
    Treatment: HiDAC + glasdegib (experimental arm) compared to HiDAC + placebo (control arm)
    Population: all patients fulfilling the in- and exclusion criteria
    Variable: Event-free survival (EFS) defined as the time from randomization to time until one of the following events, whichever occurs first: a) failure to obtain complete remission (CR) or complete remission with incomplete hematological recovery (CRi), b) relapse from complete remission for patients with induction success or c) death from any cause.
    Post-randomisation events: death from any cause is incorporated into the variable definition (composite strategy); changes in treatment and termination of treatment will be ignored (treatment policy strategy); event-free patients at the end of the follow-up period will be censored and patients who were lost to follow up or dropped out of the trial will be censored at the last observation (hypothetical strategy).
    Summary measure: Hazard ratio for the endpoint disease-free survival between the two treatment arms
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    E.5.2Secondary end point(s)
    • Complete remission rate (CRR), defined as the proportion of patients experiencing CR/CRi after induction therapy

    • Relapse-free survival (RFS), defined as the time from achievement of CR/CRi after randomization to time of recurrence of the disease or death from any cause, whatever occurs first. Patients without an applicable event are censored on the last date of follow-up. [time frame: up to LPLV]

    • Overall survival (OS), defined as the time from randomization to time of death from any cause. Patients without an applicable event are censored on the last date of follow-up. [time frame: up to LPLV]

    • Patient-Reported Outcomes including Quality of Life:
    o Health-related quality of life (QoL) is calculated as the new EORTC QLQ-C30 Summary Score recommended by the EORTC Quality of Life Group, which has been recently developed and evaluated [41]. In addition, the EORTC QLQ function and symptom scores is calculated according to the actual EORTC Scoring Manual [42].
    o Fatigue is calculated from the EORTC QLQ-FA12 according to the EORTC Scoring Manual [42].
    o Sleep problems is calculated from the PSQI according to the corresponding scoring guidelines [43].
    o Perceived cognitive impairments and impact of cognitive changes is calculated from the FACT-cog according to the corresponding scoring manual.
    o Anxiety is calculated from the PHQ-4 according to the corresponding scoring manual [44].
    o Depression is calculated from the PHQ-4 according to the corresponding scoring manual [44].
    o Health state utilities are calculated based on the SF-36 generic instrument [45].
    • Effectiveness of the investigational treatment is measured using the SF-36 generic instrument. A preference based single index is calculated using the SF-6D measure that facilitates obtaining health utilities and quality adjusted life years (QALYs).
    • Health care resource utilization and costs are measured through the treatment course. Resource units and unit costs are collected separately by self-administered questionnaires at the end of each cycle and 3-monthly during maintenance therapy, as well as using relevant data from the eCRF and German reimbursement database.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned25
    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 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
    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: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state252
    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)
    The period of treatment ends with the last visit of the sixth cycle of the maintenance therapy (EOT). After EOT patients are routinely followed-up and treated regarding standard of care according to the discretion of the treating physician. The period of observation (and the study) ends for all patients when the last patient being included and alive has been followed for at least 730 days (2 years) counted from this patient’s day 1 (EOS).
    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 Decision2020-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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