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    Summary
    EudraCT Number:2021-006515-28
    Sponsor's Protocol Code Number:ASST_FARM_2021TMO_FT14
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-14
    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 number2021-006515-28
    A.3Full title of the trial
    Prospective Phase II study on Safety and Efficacy of Fludarabine plus Treosulfan (14g) (FT14) conditioning regimen for allogeneic Stem Cell Transplantation (allo-SCT) in Acute Myeloid Leukemia (AML) patients (=40 <65years)
    Studio Prospettico di fase II sulla sicurezza e l’efficacia del regime di condizionamento con Fludarabina più Treosulfano (14g) (FT14) nel Trapianto Allogenico di Cellule Staminali (allo-TCSE) in pazienti con Leucemia Acuta Mieloide (LAM) (=40 <65 anni)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study on the safety and efficacy of fludarabine and threosulfan (14g) (FT14) as a conditioning regimen for Allogeneic Hematopoitic Stem Cell Transplantation for patients with acute myeloid leukemia aged 40 to 65 years
    Studio di Fase II su sicurezza ed efficacia di fludarabina e treosulfano (14g) (FT14) come regime di condizionamento per Trapianto di Cellule Staminali Ematopoitiche Allogeniche per pazienti affetti da Leucemia acuta mieloide di età compresa tra i 40 e 65 anni
    A.3.2Name or abbreviated title of the trial where available
    FT14 - Trial
    FT14 - Trial
    A.4.1Sponsor's protocol code numberASST_FARM_2021TMO_FT14
    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 SponsorAZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    B.1.3.4CountryItaly
    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 supportMEDAC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASST SPEDALI CIVILI DI BRESCIA
    B.5.2Functional name of contact pointPROGETTAZIONE RICERCA E STUDI DI FA
    B.5.3 Address:
    B.5.3.1Street AddressP.LE SPEDALI CIVILI 1
    B.5.3.2Town/ cityBRESCIA
    B.5.3.3Post code25123
    B.5.3.4CountryItaly
    B.5.4Telephone number0303996851
    B.5.5Fax number0303996125
    B.5.6E-mailcoordinamento.ricerca@asst-spedalicivili.it
    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 FLUDARABINA TEVA - 25 MG/ML CONCENTRATO PER SOLUZIONE INIETTABILE O PER INFUSIONE 1 FLACONCINO DI VETRO DA 2 ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA S.R.L.
    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 nameFLUDARABINA
    D.3.2Product code [FLUDARABINA]
    D.3.4Pharmaceutical form 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 INNFLUDARABINA
    D.3.9.2Current sponsor codefludarabina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.2.1.1.1Trade name trecondi
    D.2.1.1.2Name of the Marketing Authorisation holdermedac italia
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTreosulfan
    D.3.2Product code [Treosulfan]
    D.3.4Pharmaceutical form Powder 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 INNtreosulfan
    D.3.9.2Current sponsor codetreosulfan
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    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 (AML) patients (=40 <65years)
    in pazienti con Leucemia Acuta Mieloide (LAM) (=40 <65 anni)
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia (AML) patients (=40 <65years)
    pazienti con Leucemia Acuta Mieloide (LAM) (=40 <65 anni)
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of the FT14 conditioning regimen for allo-SCT in AML patients (=40 <65years) in complete morphological remission (CR/CRi/MLFS)
    Valutare la sicurezza e l’efficacia del regime di condizionamento FT-14 nel Trapianto Allogenico di Cellule Staminali Emopoietiche (allo-TCSE) in pazienti con Leucemia Acuta Mieloide (LAM) in remissione morfologica completa (CR/CRi/MLFS) di età compresa tra 40 e 65 anni.
    E.2.2Secondary objectives of the trial
    Cumulative incidence of graft failure at +30 days, +100 days from transplant
    - Incidenza cumulativa di fallimento della procedura a + 30 giorni e + 100 giorni dal Trapianto;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ¿ Patients >40 <65 years of age
    ¿ Diagnosis of AML in first CR/CRi/ MLFS
    ¿ eligible for allo-SCT from HLA-identical matched related or unrelated donor as defined by molecular high-resolution typing ( 4 digits) at the following four HLA gene loci (HLA-A, B, C, and DRB1);
    ¿ adequate hepatic function (bilirubin =2 UNL; ALT/AST =2,5 UNL)
    ¿ adequate renal function (creatinine clearance =50 ml/min)
    ¿ ECOG Performance Status < 2
    ¿ Willing and able to comply with all of the requirements and visits in the protocol.
    ¿ Written and signed informed consent.
    ¿ Pazienti con età >40 <65 anni;
    ¿ Diagnosi di LAM in prima CR/CRi/ MLFS;
    ¿ Paziente eleggibile per allo-TCSE da donatore relato o non relato HLA-identico come definito dalla tipizzazione molecolare ad alta risoluzione (4 cifre) ai seguenti loci HLA (HLA-A; HLA-B; HLA-C e DRB1;
    ¿ Funzionalità epatica adeguata, definite come:
    ¿ Bilirubina =2 UNL;
    ¿ ALT/AST =2.5 ULN;
    ¿ Funzionalità renale adeguata, definite come:
    ¿ Clearance creatinina =50 mL/min;
    ¿ ECOG Performance Status < 2;
    ¿ Paziente disponibile ed in grado di soddisfare tutti i requisiti e le visite di protocollo;
    ¿ Consenso informato sottoscritto e firmato.
    E.4Principal exclusion criteria
    ¿ AML patients with t(15;17); t(8;21); inv(16)
    ¿ Subject has known active CNS involvement with AML.
    ¿ grade >2 NCI-CTCAE (v. 5) adverse events at the time of enrollment
    ¿ Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min.
    ¿ The evidence of HBV or HCV active infection (HBV DNA, HCV RNA positive test).
    ¿ Patients with HIV infection
    ¿ Current uncontrolled infections
    ¿ Patients with other life-threatening concurrent disease
    ¿ Subjects with known hypersensitivity to any of the component medication
    ¿ Participation in another clinical trial within 1 month before the start of this trial.
    ¿ Pazienti con LAM con t(15;17); t(8;21); inv(16);
    ¿ Coinvolgimento attivo del SNC con LAM;
    ¿ Eventi avversi di grado > 2 NCI-CTCAE (v. 5) al momento dell’arruolamento;
    ¿ Disfunzioni organiche gravi, definite come:
    ¿ frazione di eiezione ventricolare sinistra <40%;
    ¿ FEV1, FVC e DLCO <40% rispetto al valore atteso;
    ¿ LFT > 5 volte ULN o clearance creatinina < 40 mL/min;
    ¿ Infezione attiva da HBV o HCV (positività ad HBV DNA o HCV RNA);
    ¿ Pazienti con infezione da HIV;
    ¿ Infezioni incontrollate in corso;
    ¿ Pazienti con altre malattie ritenute pericolose per la vita;
    ¿ Soggetti con nota ipersensibilità ad uno dei componenti del farmaco;
    ¿ Partecipazione in un altro studio clinico nel mese precedente
    E.5 End points
    E.5.1Primary end point(s)
    The 1-year leukemia -free survival (LFS) after allo-SCT
    sopravvivenza libera da leucemia (LFS) a 1 anno dopo allo-SCT
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 month
    12 mesi
    E.5.2Secondary end point(s)
    Cumulative incidence of graft failure at +30 days, +100 days from transplant; Cumulative incidence and severity of acute GvHD at 100 days after transplant; Cumulative incidence and severity of chronic GvHD at 1 and 2 years post transplant; RI at 1 and 2 year after transplantation from days of transplant.
    - OS at 1 and 2 years post transplant
    - LFS at 1 and 2 years post transplant; 1 and 2 year probability of GRFS
    - Incidenza cumulativa di fallimento della procedura a + 30 giorni e + 100 giorni dal Trapianto;; Incidenza cumulativa e severità della GvHD acuta al giorno + 100 dal Trapianto;; Incidenza cumulativa e severità della GvHD croncia ad 1 e 2 anni dal Trapianto;; - RI a 1 e 2 anni dal Trapianto;
    - OS a 1 e 2 anni post TCSE;
    - LFS a 1 e 2 anni post TCSE;; - Probabilità di GRFS 1 e 2 anni dal Trapianto
    E.5.2.1Timepoint(s) of evaluation of this end point
    +30 days, +100 days from transplant; 100 days after transplant; at 1 and 2 years post transplant; at 1 and 2 year after transplantation; 1 and 2 year post transplant
    30 giorni e + 100 giorni dal Trapianto;; 100 dal Trapianto; ad 1 e 2 anni dal Trapianto; 1 e 2 anni dal Trapianto;; 1 e 2 anni dal Trapianto
    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 No
    E.6.5Efficacy No
    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 No
    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.8.2.4Number 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 concerned15
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months0
    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 months0
    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: 82
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state82
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 82
    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)
    patients will be treated according to the standards of care provided by the national health system
    i pazienti saranno trattati secondo gli standard di cura previsti dal sistema sanitario nazionale
    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 Decision2022-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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