Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-001611-12
    Sponsor's Protocol Code Number:56022473AML2002
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-15
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-001611-12
    A.3Full title of the trial
    A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus JNJ-56022473
    (Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are not
    Candidates for Intensive Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.
    A.4.1Sponsor's protocol code number56022473AML2002
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3171524 2166
    B.5.5Fax number+3171524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-56022473
    D.3.2Product code JNJ-56022473
    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 INNTalacotuzumab
    D.3.9.2Current sponsor codeJNJ-56022473
    D.3.9.4EV Substance CodeSUB176319
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 DACOGEN
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameDACOGEN
    D.3.2Product code DACOGEN
    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 INNDECITABINE
    D.3.9.1CAS number 2353-33-5
    D.3.9.2Current sponsor codeDACOGEN
    D.3.9.3Other descriptive nameDACOGEN
    D.3.9.4EV Substance CodeSUB06932MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Acute Myeloid Leukemia (AML)
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia (AML)
    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 LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000012984
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: The primary objectives of Part A of the study are to assess safety and to confirm the recommended Phase 2 dose (RP2D) of JNJ-56022473 monotherapy.
    Part B: The primary objectives of Part B of the study are to assess complete response (CR) rate and overall survival (OS) in patients with previously untreated AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus JNJ-56022473 at the RP2D or decitabine alone.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the event-free survival (EFS), the overall response rate (ORR, defined as the rate of CR + complete response with incomplete blood count recovery [CRi]), the rate of CR plus MRD negative CRi, the relapse-free survival (RFS), time to and duration of response, and the safety profile of study treatments; to
    assess the pharmacokinetics (PK) of decitabine and JNJ-56022473 when used alone or in combination; to assess the immunogenicity of JNJ-56022473 in combination with decitabine, to evaluate minimal residual disease (MRD) and to evaluate patient-reported outcomes measures (PRO) using the FACT LEU and
    EQ-5D-5L instruments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    De novo or secondary acute myeloid leukemia (AML) according to WHO 2008 criteria
    For Part A:
    -Participants With AML: treatment naive or relapsed for whom experimental therapy is appropriate (as assessed by their treating physician)
    For Part B:
    >/= 75 years of age or
    65 up to 75 years of age and have at least one of the following:
    -Congestive heart failure or ejection fraction ≤50%
    -Creatinine >2 mg/dL, dialysis or prior renal transplant
    -Documented pulmonary disease with lung diffusing capacity for carbon
    monoxide (DLCO) ≤65% of expected, or forced expiratory volume in 1
    second (FEV1) ≤65% of expected or dyspnea at rest requiring oxygen
    -ECOG performance status of 2
    -Prior or current malignancy that does not require concurrent treatment
    -Unresolved infection
    -Comorbidity that, in the Investigator's opinion, makes the patient
    unsuitable for intensive chemotherapy and must be documented and
    approved by the Sponsor before randomization
    -De novo or secondary AML (post myelodysplastic syndrome [MDS] or
    myeloproliferative neoplasm [MPN] or after leukemogenic
    chemotherapy)
    Previously untreated AML (except: emergency leukapheresis and/or
    hydroxyurea during the screening phase to control hyperleukocytosis
    but must be discontinued at least one day prior to start of study therapy);

    -Not eligible for standard intensive chemotherapy for induction and consolidation based on documented investigator assessment of disease and patient characteristics as recorded in the electronic case report form (eCRF); these parameters include age, Eastern Cooperative Oncology Group (ECOG) performance status score, cytogenetic risk group, and comorbidities (cardiac, infectious, hepatic, diabetes related, pulmonary, obesity related, cerebrovascular accident related, peptic ulcer, and others
    -Not eligible for an allogeneic hematopoietic stem cell transplantation
    ECOG Performance Status score of 0, 1 or 2
    -A woman must be either: Not of childbearing potential: postmenopausal
    (more than [>] 45 years of age with amenorrhea for at least 12 months; If,
    of childbearing potential must be practicing a highly effective method of
    birth control
    -A woman of childbearing potential must have a negative serum (betahuman
    chorionic gonadotropin [betahCG]) or urine pregnancy test at screening
    -A man who is sexually active with a woman of childbearing potential and
    has not had a vasectomy must agree to use a barrier method of birth
    control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for at least 3 months after last study treatment
    E.4Principal exclusion criteria
    -Acute promyelocytic leukemia with t(15;17), or its molecular equivalent
    (PMLRARalpha)

    -For Part B only: Known leukemic involvement or clinical symptoms of
    leukemic involvement of the central nervous system

    -Participants who received prior treatment with a hypomethylating agent

    -ForPart A only: Participants who did not recover from all clinically
    significant toxicities (excluding alopecia and hematologic toxicities) of any
    previous surgery, radiotherapy, targeted therapy, or chemotherapy to
    less than or equal to Grade 1

    -A diagnosis of other malignancy that requires concurrent treatment
    -Any uncontrolled active systemic infection that requires treatment with
    IV antibiotics
    -Active systemic hepatitis infection requiring treatment or other
    clinically active liver disease
    E.5 End points
    E.5.1Primary end point(s)
    1-Complete Response Rate
    2-Overall Survival
    3 - Rate of CR plus MRD negative CRi
    4-Relapse free survival (RFS)
    5- Number of Participants With Adverse Event
    6-Number of Participants With Anti-drug Antibody at any Visit
    7-Functional Assessment of Cancer Therapy Leukemia (FACT-Leu) Score
    8-European Quality of Life- 5 Dimension 5 Level (EQ-5D-5L) Score
    9-Area under the concentration- time curve between time t1 and t2 (AUC
    t1-t2)
    10-Total Systemic Clearance (CL)
    11- Maximum Observed Serum Concentration (Cmax)
    12- Minimum Observed Concentration (Cmin)
    13- Volume of Distribution
    14-Time to Response
    15- Duration of Response
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- Disease assessment will continue until treatment failure or relapse or clinical cutoff (Approximately up to 4 years after first participant enrollment)
    2-Approximately up to 4 years after first participant enrollment
    E.5.2Secondary end point(s)
    1-Overall response rate (ORR)
    2- Event Free Survival (EFS)
    3-Relapse free survival (RFS)
    4- Number of Participants With Adverse Event
    5-Number of Participants With Anti-drug Antibody at any Visit
    6-Functional Assessment of Cancer Therapy Leukemia (FACT-Leu) Score
    7-European Quality of Life- 5 Dimension 5 Level (EQ-5D-5L) Score
    8-Area under the concentration- time curve between time t1 and t2 (AUC t1-t2)
    9-Total Systemic Clearance (CL)
    10- Maximum Observed Serum Concentration (Cmax)
    11- Minimum Observed Concentration (Cmin)
    12- Volume of Distribution
    13-Time to Response
    14- Duration of Response
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Disease assessment will continue until treatment failure or relapse or clinical cutoff (Approx up to 4 years after first participant enrollment)
    2-5: Approximately up to 4 years after first participant enrollment
    6-7: Baseline to first followup after completion of study treatment, up to 4 years after first participant enrollment
    8-12: Pre-specified time points during treatment through Cycle 1 (Days 1,2,3,4,8), cyc 2(Day 1), cyc 3,5 (Day 8) for part A and Cycle 1,4 (Days 1,5,8,9,22,23) cyc 2 (Days 1,8) for part B and also up to 30 days after last dose of any study drug in part A and B
    13-14: Disease assessment will continue until treatment failure or relapse or clinical cutoff (Approximately up to 4 years after first participant enrollment)
    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 Yes
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    DACOGEN
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Australia
    Belgium
    France
    Germany
    Israel
    Italy
    Korea, Democratic People's Republic of
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Sweden
    Taiwan
    Turkey
    United Kingdom
    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 the study is defined as when 270 deaths have occurred or at 6 months after the last subject is enrolled, whichever occurs first. At that time, follow up of subjects and data collection will end. Subjects who are continuing to derive benefit from treatment as assessed by their investigator will continue to receive treatment and be monitored for safety by the sponsor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 400
    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 the end of study, follow up of subjects and data collection will end. Subjects who are continuing to derive benefit from treatment as assessed by their investigator and confirmed by the study evaluation team will continue to receive treatment and be monitored for safety by the sponsor.
    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 Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA