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    The EU Clinical Trials Register currently displays   37196   clinical trials with a EudraCT protocol, of which   6122   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2018-001588-22
    Sponsor's Protocol Code Number:AML003
    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:2019-02-08
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2018-001588-22
    A.3Full title of the trial
    Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (devimistat) in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in Older Patients (≥ 50 years) with Relapsed/Refractory Acute Myeloid Leukemia (AML)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical study to determine the efficacy and safety of CPI-613® (devimistat) in combination with high dose Cytarabine and Mitoxantrone compared to high dose Cytarabine and Mitoxantrone in adults with a type of cancer called acute myeloid leukemia
    A.3.2Name or abbreviated title of the trial where available
    ARMADA 2000
    A.4.1Sponsor's protocol code numberAML003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03504410
    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 SponsorRafael Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRafael Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRafael Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address1 Duncan Drive
    B.5.3.2Town/ cityCranbury
    B.5.3.3Post codeNJ 08512
    B.5.3.4CountryUnited States
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2123
    D.3 Description of the IMP
    D.3.1Product nameCPI-613
    D.3.2Product code CPI-613
    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 INNdevimistat (Rafael Pharmaceuticals)
    D.3.9.1CAS number 95809-78-2
    D.3.9.2Current sponsor codeCPI-613
    D.3.9.3Other descriptive name6,8-BIS(BENZYLTHIO)OCTANOIC ACID
    D.3.9.4EV Substance CodeSUB187819
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E.1.1.1Medical condition in easily understood language
    A blood cancer called Acute Myeloid Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid 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 determine efficacy of CHAM in terms of complete remission (CR) and
    compare with HAM (control). CR will be determined as per standard
    response criteria for AML (Döhner et al. 2017; 129[4]:424-447).
    E.2.2Secondary objectives of the trial
    1. To determine efficacy of CHAM in terms of overall survival (OS) and
    complete remission + complete remission with partial hematologic
    recovery (CR+CRh) as the two key secondary objectives to compare with
    HAM (control). The OS and CR+CRh will be determined as per standard
    response criteria for AML (Döhner et al. 2017; 129[4]:424-447).
    2. Safety: The assessment of safety will be based mainly on the
    frequency of adverse events (AEs) based on the Common Terminology
    Criteria for AEs (version 5.0 or later) grade. Adverse events will be
    coded according to the Medical Dictionary for Regulatory Activities
    (MeDRA (version 22.0 or higher). The safety outcomes will include the
    occurrence of at least one serious AE, of at least one Grade 3/4 AE, and
    of at least one AE requiring the discontinuation of study treatment.
    Electrocardiogram QTc intervals and cardiac markers will also be
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females age ≥ 50 years must have histologically
    documented AML that is relapsed from, or refractory to, prior standard
    2. Refractory is defined as failure to achieve CR or complete remission
    with incomplete recovery (CRi) following:
    - Two standard dose Cytarabine based induction cycles or one High Dose
    Cytarabine (HiDAC) based cycle, or
    - Persistent disease after one cycle of standard dose cytarabine (defined as no decrease in marrow blast percentage from diagnosis on Day 14
    marrow) or
    Persistent disease after at least 2 cycles of a hypomethylating agent
    (azacytidine or decitabine) with or without venetoclax
    3. Relapse is defined as development of recurrent AML (Döhner et al.
    2017; 129[4]:424-447) after CR or CRi has been achieved with a prior
    chemotherapy or after disease progression on a hypomethylating agent
    with or without venetoclax
    4. ECOG PS (performance score) 0-2
    5. Expected survival greater than 3 months
    E.4Principal exclusion criteria
    1. Patients who have received previous cytotoxic chemotherapy
    treatment for their relapsed or refractory AML. Previous treatment with
    hypomethylating agents (decitabine or azacytidine) either alone or in
    combination with Venetoclax is allowed. Targeted therapies including
    FLT3 or IDH1/2 inhibitors or Hydrea or venetoclax are allowed. Targeted
    therapies and Hydrea may be taken until the day prior to starting CHAM
    or HAM therapy
    2. Female patients who are pregnant or breastfeeding or planning to
    become pregnant or breastfeed during treatment and for an additional 6
    months after the last dose of CHAM or HAM therapy (the teratogenic
    potential of CPI-613® (devimistat) is unknown). Female patients of
    childbearing potential with a positive pregnancy test assessed by a
    serum pregnancy test at Screening
    3. Patients receiving any other standard or investigational treatment for
    AML, or any other investigational agent for any indication within the past
    1 week prior to initiation of CPI-613® (devimistat) treatment (the use of
    Hydrea and/or venetoclax, oral tyrosine kinase inhibitors FLT3 or IDH
    1/2 inhibitors is allowed until the day prior to starting CHAM or HAM
    therapy). Previous exposure to a hypomethylating agent either alone or
    in combination with venetoclax is allowed.
    4. Patients who have received immunotherapy of any type within the
    past 1 week prior to initiation of CPI-613® (devimistat) treatment.
    5. Requirement for immediate palliative treatment of any kind including
    minor surgery
    6. Patients who have received a chemotherapy regimen with autologous
    stem cell support (bone marrow transplantation) within 6 months of
    starting CHAM or HAM therapy.
    7. Patients who have had allogenic bone marrow transplantation within
    the last 6 months. Patients who have had an allogenic transplant more
    than 6 months ago are eligible provided they have no graft vs host
    E.5 End points
    E.5.1Primary end point(s)
    CR (Complete Remission).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1st Interim Analysis, 2nd Interim Analysis and Final Analysis
    E.5.2Secondary end point(s)
    1. OS (key secondary)
    2. CR+CRh (key secondary)
    3. Safety
    4. PK
    5. PRO by EORTC QLQ C30
    6. Cancer-associated mutations and/or genetic alterations in bone marrow aspirate/biopsy and/or peripheral blood.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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. 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Cytarabine, Mitoxantrone
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Korea, Republic of
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months41
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months46
    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: 100
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 264
    F.4.2.2In the whole clinical trial 500
    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 a patient has completed / terminated the study, any of the available treatments for AML will be provided at the discretion of the investigator as per standard of care.
    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 Decision2020-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-05
    P. End of Trial
    P.End of Trial StatusOngoing
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