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    Summary
    EudraCT Number:2018-001588-22
    Sponsor's Protocol Code Number:AML003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-01
    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 ConcernedItaly - Italian Medicines Agency
    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)
    Sperimentazione multicentrica di fase III, in aperto, randomizzata per valutare
    l’efficacia e la sicurezza di CPI-613® (devimistat) in combinazione con citarabina
    ad alto dosaggio e mitoxantrone (CHAM) rispetto a citarabina ad alto dosaggio e
    mitoxantrone (HAM) in pazienti anziani (=50 anni) con leucemia mieloide acuta
    (LMA) recidivante/refrattaria
    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
    Uno studio clinico di fase III per determinare l'efficacia e la sicurezza di CPI-613® (devimistat) in combinazione con citarabina e Mitoxantrone ad alte dosi rispetto a citarabina e mitoxantrone ad alte dosi negli adulti con un tipo di tumore chiamato leucemia mieloide acuta
    A.3.2Name or abbreviated title of the trial where available
    ARMADA 2000
    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
    B.5.6E-mailsanjeev.luther@rafaelpharma.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 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 injection/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
    D.3.9.1CAS number 95809-78-2
    D.3.9.2Current sponsor codeCPI-613
    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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 injection/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
    D.3.9.1CAS number 95809-78-2
    D.3.9.2Current sponsor codeCPI-613
    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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    leucemia mieloide acuta
    E.1.1.1Medical condition in easily understood language
    A blood cancer called Acute Myeloid Leukemia
    Un tumore del sangue chiamato leucemia mieloide acuta
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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).
    Determinare l’efficacia di CHAM in termini di remissione completa (CR) e confrontarla con HAM (controllo). La CR sarà determinata secondo i criteri di risposta standard per la LMA (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 evaluated.
    Determinare l’efficacia di CHAM in termini di sopravvivenza globale (OS) e remissione completa + remissione completa con parziale recupero ematologico (CR+CRh) come i due principali obiettivi secondari da confrontare con HAM (controllo). OS e CR+CRh saranno determinati secondo i criteri di risposta standard per la LMA (Döhner et al. 2017; 129[4]: 424-447).
    ¿ Sicurezza: La valutazione della sicurezza si baserà principalmente sugli la frequenza di eventi avversi (EA) in base al grado indicato nei Criteri comuni di terminologia per gli EA (versione 5,0 o successiva). Gli eventi avversi saranno codificati in base al Dizionario medico per le attività regolatorie (MeDRA, versione 22.0 o successiva). Gli esiti di sicurezza includeranno il verificarsi di almeno un EA grave, di almeno un EA di grado 3/4 e di almeno un EA che richieda la sospensione del trattamento dello studio. Saranno valutati anche i marcatori cardiaci e gli intervalli QTc degli elettrocardiogrammi.
    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 therapies
    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
    ¿ Soggetti di sesso maschile e femminile di età =50 anni che devono essere affetti da una forma di LMA confermata istologicamente che mostri recidiva alle precedenti terapie standard o risulti refrattaria alle stesse.
    ¿ Per refrattaria si intende l’impossibilità di ottenere una CR o una remissione completa con recupero incompleto (CRi) in seguito a:
    - Due cicli di induzione a base di citarabina a dosaggio standard o un ciclo a base di citarabina ad alto dosaggio (HiDAC), oppure
    - Malattia persistente dopo un ciclo con citarabina a dosaggio standard, (definita come l’assenza di riduzione nella percentuale di blasti nel midollo osseo dalla diagnosi al Giorno 14); oppure
    - Malattia persistente dopo almeno 2 cicli di un agente ipometilante (azacitidina o decitabina) con o senza venetoclax
    La recidiva è definita come lo sviluppo di LMA recidivante (Döhner et al. 2017; 129[4]: 424-447) dopo il raggiungimento di una CR o CRi con una precedente chemioterapia o dopo progressione della malattia durante la terapia con un agente ipometilante con o senza venetoclax.
    ¿ PS ECOG (punteggio di validità) 0-2.
    ¿ Aspettativa di vita maggiore di 3 mesi.
    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 disease.
    Pazienti che hanno ricevuto un precedente trattamento chemioterapico citotossico per la loro LMA recidivante o refrattaria. È consentito un precedente trattamento con agenti ipometilanti (decitabina o azacitidina) in monoterapia o in combinazione con venetoclax. Le terapie mirate, compresi gli inibitori di FLT3, IDH1/2 o Hydrea o venetoclax, sono consentite. Le terapie mirate e Hydrea possono essere assunte fino al giorno precedente l’inizio della terapia con CHAM o HAM.
    ¿ Pazienti di sesso femminile in gravidanza o che stanno allattando al seno o che prevedono di avviare una gravidanza o allattare al seno durante il trattamento e per altri 6 mesi dopo l’ultima dose della terapia con CHAM o HAM (il potenziale teratogeno di CPI-613® [devimistat] non è noto). Pazienti di sesso femminile in età fertile con un test di gravidanza positivo valutato mediante un test di gravidanza sul siero eseguito allo screening.
    Pazienti che ricevono qualsiasi altro trattamento standard o sperimentale per la LMA o qualsiasi altro agente sperimentale per qualsiasi indicazione nell’ultima settimana precedente l’inizio del trattamento con CPI-613® (devimistat) (l’uso di Hydrea e/o venetoclax, inibitori tirosin-chinasici orali di FLT3 o inibitori di IDH1/2 è consentito fino al giorno precedente l’inizio della terapia con CHAM o HAM). La precedente esposizione a un agente ipometilante in monoterapia o in combinazione con venetoclax è consentita.
    ¿ Pazienti che hanno ricevuto immunoterapia di qualsiasi tipo nell’ultima settimana precedente l’inizio del trattamento con CPI-613® (devimistat).
    ¿ Necessità di un trattamento palliativo immediato di qualsiasi tipo, compresi interventi chirurgici minori.
    ¿ Pazienti che hanno ricevuto un regime chemioterapico con supporto di cellule staminali autologhe (trapianto di midollo osseo) entro 6 mesi dall’inizio della terapia con CHAM o HAM.
    ¿ Pazienti che si sono sottoposti a un trapianto allogenico di midollo osseo negli ultimi 6 mesi. I pazienti sottoposti a un trapianto allogenico oltre 6 mesi prima sono idonei purché non colpiti da malattia del trapianto contro l’ospite
    E.5 End points
    E.5.1Primary end point(s)
    CR (Complete Remission).
    CR
    E.5.1.1Timepoint(s) of evaluation of this end point
    1st Interim Analysis, 2nd Interim Analysis and Final Analysis
    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.

    OS (secondario principale)
    ¿ CR+CRh (secondario principale)
    ¿ Sicurezza
    ¿ PK
    ¿ PRO valutati mediante il QLQ-C30 dell’EORTC
    ¿ Mutazioni e/o alterazioni genetiche associate al tumore in biopsie/aspirati del midollo osseo e/o nel sangue periferico.
    Endpoint esplorativi:
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Fine studio
    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.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 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.8.2.3.1Comparator description
    Cytarabine, Mitoxantrone
    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 concerned11
    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 Information not present in EudraCT
    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
    Canada
    Korea, Republic of
    United States
    Belgium
    France
    Germany
    Italy
    Poland
    Spain
    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 years0
    E.8.9.1In the Member State concerned months41
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months46
    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: 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 state88
    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)
    None
    nessuno
    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 Decision2020-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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