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Eine Studie zu Ivosidenib oder Enasidenib in Kombination mit Induktionstherapie und Konsolidierungstherapie, gefolgt von einer Erhaltungstherapie bei Patienten mit neu diagnostizierter akuter myeloischer Leukämie oder myedysplastischem Syndrom EB2, mit einer IDH1- bzw. IDH2-Mutation, die für eine intensive Chemotherapie geeignet sind (HOVON150AML)

17. September 2026 aktualisiert von: Stichting Hemato-Oncologie voor Volwassenen Nederland

Eine multizentrische, doppelblinde, randomisierte, placebokontrollierte Phase-3-Studie mit Ivosidenib oder Enasidenib in Kombination mit einer Induktionstherapie und einer Konsolidierungstherapie, gefolgt von einer Erhaltungstherapie bei Patienten mit neu diagnostizierter akuter myeloischer Leukämie oder myelodysplastischem Syndrom mit exzessiven Blasten-2, mit eine IDH1- bzw. IDH2-Mutation, die für eine intensive Chemotherapie geeignet ist.

AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

968

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
      • Adelaide, Australien
        • AU-Adelaide-FLINDERS
      • Adelaide, Australien
        • AU-Adelaide-RAH
      • Brisbane, Australien
        • AU-Brisbane-PAH
      • Camperdown, Australien
        • AU-Camperdown-RPA
      • Canberra, Australien
        • AU-Canberra-CANBERRAHOSPITAL
      • Douglas, Australien
        • AU-Douglas-TOWNSVILLE
      • Hobart, Australien
        • AU-Hobart TAS-RHOBART
      • Launceston, Australien
        • AU-Launceston TAS-LAUNCESTON
      • Melbourne, Australien
        • AU-Melbourne-ALFRED
      • Melbourne, Australien
        • AU-Melbourne-AUSTIN
      • Melbourne, Australien
        • AU-Melbourne-MONASH
      • Melbourne, Australien
        • AU-Melbourne-RMELBOURNE
      • Melbourne, Australien
        • AU-Melbourne-SVHM
      • Perth, Australien
        • AU-Perth-FSH
      • Perth, Australien
        • AU-Perth-RPH
      • Perth, Australien
        • AU-Perth-SCGH
      • Sydney, Australien
        • AU-Sydney-CONCORD
      • Sydney, Australien
        • AU-Sydney-RNSH
      • Sydney, Australien
        • AU-Sydney-WSAH
      • Sydney, Australien
        • AU-Sydney-SVHS
      • Waratah, Australien
        • AU-Waratah-CALVARYMATER
  • Belgien
      • Antwerp, Belgien
        • BE-Antwerpen-ZNASTUIVENBERG
      • Bruges, Belgien
        • BE-Brugge-AZBRUGGE
      • Brussels, Belgien
        • BE-Bruxelles-STLUC
      • Brussels, Belgien
        • BE-Brussel-BORDET
      • Brussels, Belgien
        • BE-Brussel-UZBRUSSEL
      • Ghent, Belgien
        • BE-Gent-UZGENT
      • Haine-Saint-Paul, Belgien
        • BE-Haine-Saint-Paul-JOLIMONT
      • Hasselt, Belgien
        • BE-Hasselt-VIRGAJESSE
      • Leuven, Belgien
        • BE-Leuven-UZLEUVEN
      • Liège, Belgien
        • BE-Liege-CHRCITADELLE
      • Liège, Belgien
        • BE-Liege-CHULIEGE
      • Roeselare, Belgien
        • BE-Roeselare-AZDELTA
      • Yvoir, Belgien
        • BE-Yvoir-MONTGODINNE
  • Deutschland
      • Bad Saarow, Deutschland
        • DE-Bad Saarow-HELIOSBADSAAROW
      • Berlin, Deutschland
        • DE-Berlin-CAMPUSBENFRANKLIN
      • Berlin, Deutschland
        • DE-Berlin-CAMPUSVIRCHOW
      • Berlin, Deutschland
        • DE-Berlin-VIVANTESNEUKOLLN
      • Berlin, Deutschland
        • DE-Berlin-VIVANTESURBAN
      • Bochum, Deutschland
        • DE-Bochum-RUB
      • Bonn, Deutschland
        • DE-Bonn-UNIBONN
      • Braunschweig, Deutschland
        • DE-Braunschweig-KLINIKUMBRAUNSCHWEIG
      • Bremen, Deutschland
        • DE-Bremen-KBM
      • Dortmund, Deutschland
        • DE-Dortmund-JOHODORTMUND
      • Düsseldorf, Deutschland
        • DE-Düsseldorf-MEDUNIDUESSELDORF
      • Essen, Deutschland
        • DE-Essen-KEM
      • Esslingen am Neckar, Deutschland
        • DE-Esslingen-KLINIKUMESSLINGEN
      • Flensburg, Deutschland
        • DE-Flensburg-MALTESER
      • Giessen, Deutschland
        • DE-Giessen-UKGM
      • Goch, Deutschland
        • DE-Goch-KKLE
      • Hamburg, Deutschland
        • DE-Hamburg-ASKLEPIOSSTGEORG
      • Hamburg, Deutschland
        • DE-Hamburg-ASKLEPIOS
      • Hamburg, Deutschland
        • DE-Hamburg-UKE
      • Hamm, Deutschland
        • DE-Hamm-EVKHAMM
      • Hanau, Deutschland
        • DE-Hanau-KLINIKUMHANAU
      • Hanover, Deutschland
        • DE-Hannover-MHHANNOVER
      • Hanover, Deutschland
        • DE-Hannover-SILOAHKRH
      • Herne, Deutschland
        • DE-Herne-MARIENHOSPITALHERNE
      • Homburg, Deutschland
        • DE-Homburg-UNIKLINIKSAARLAND
      • Karlsruhe, Deutschland
        • DE-Karlsruhe-KLINIKUMKARLSRUHE
      • Lebach, Deutschland
        • DE-Lebach-CARITASKHLEBACH
      • Lemgo, Deutschland
        • DE-Lemgo-KLINIKUMLIPPE
      • Ludwigshafen, Deutschland
        • DE-Ludwigshafen-KLILU
      • Lüdenscheid, Deutschland
        • DE-Luedenscheid-KLINIKUMLUEDENSCHEID
      • Magdeburg, Deutschland
        • DE-Magdeburg-OVGU
      • Mainz, Deutschland
        • DE-Mainz-KLINKUNIMAINZ
      • Mainz, Deutschland
        • DE-Mainz-UNIMEDIZINMAINZ
      • Meschede, Deutschland
        • DE-Meschede-HOCHSAUERLAND
      • Minden, Deutschland
        • DE-Minden-MUEHLENKREISKLINKEN
      • München, Deutschland
        • DE-München-IRZTUM
      • München, Deutschland
        • DE-München-MEDUNIMUNCHIN
      • Offenburg, Deutschland
        • DE-Offenburg-ORTENAUKLINIKUM
      • Oldenburg, Deutschland
        • DE-Oldenburg-KLINIKUMOLDENBURG
      • Passau, Deutschland
        • DE-Passau-KLINIKUMPASSAU
      • Stuttgart, Deutschland
        • DE-Stuttgart-DIAKSTUTTGART
      • Stuttgart, Deutschland
        • DE-Stuttgart-KLINIKUMSTUTTGART
      • Traunstein, Deutschland
        • DE-Traunstein-TSSOB
      • Trier, Deutschland
        • DE-Trier-MUTTERHAUS
      • Tübingen, Deutschland
        • DE-Tübingen-MEDUNITUEBINGEN
      • Ulm, Deutschland
        • DE-Ulm-UNIKLINKULM
      • Villingen-Schwenningen, Deutschland
        • DE-Villingen-Schwenningen-SBKVS
      • Wuppertal, Deutschland
        • DE-Wuppertal-HELIOSGESUNDHEIT
  • Estland
      • Tartu, Estland
        • EE-Tartu-TARTU
  • Finnland
      • Helsinki, Finnland
        • FI-Helsinki-HUS
      • Tampere, Finnland
        • FI-Tampere-TAYS
  • Frankreich
      • Amiens, Frankreich
        • FR-Amiens-CHUAMIENS
      • Angers, Frankreich
        • FR-Angers-CHUANGERS
      • Argenteuil, Frankreich
        • FR-Argenteuil-CHARGENTEUIL
      • Bayonne, Frankreich
        • FR-Bayonne-CHCOTEBASQUE
      • Besançon, Frankreich
        • FR-Besançon Cedex-JEANMINJOZ
      • Bobigny, Frankreich
        • FR-Bobigny-AVICENNE
      • Chambéry, Frankreich
        • FR-Chambery-CHMETROPOLESAVOIE
      • Chesnay, Frankreich
        • FR-Le Chesnay cedex-CHVERSAILLES
      • Clamart, Frankreich
        • FR-Clamart-HIAPERCY
      • Clermont-Ferrand, Frankreich
        • FR-Clermont-Ferrand-ESTAING
      • Créteil, Frankreich
        • FR-Créteil cedex-CHUMONDOR
      • Grenoble, Frankreich
        • FR-Grenoble cedex 9-CHUGRENOBLE
      • Lens, Frankreich
        • FR-Lens-CHLENS
      • Lille, Frankreich
        • FR-Lille-CHULILLE
      • Limoges, Frankreich
        • FR-Limoges-CHULIMOGES
      • Lyon, Frankreich
        • FR-Lyon Pierre Benite cedex-LYONSUD
      • Lyon, Frankreich
        • FR-Lyon-LEONBERARD
      • Marseille, Frankreich
        • FR-Marseille-IPC
      • Montpellier, Frankreich
        • FR-Montpellier-STELOI
      • Mulhouse, Frankreich
        • FR-Mulhouse-GHRMSA
      • Nantes, Frankreich
        • FR-Nantes-CHUNANTES
      • Nice, Frankreich
        • FR-Nice-CAL
      • Nice, Frankreich
        • FR-Nice-LARCHET
      • Orléans, Frankreich
        • FR-Orléans-CHORLEANS
      • Paris, Frankreich
        • FR-Paris cedex 10-SAINTLOUIS
      • Paris, Frankreich
        • FR-Paris cedex 15-NECKER
      • Paris, Frankreich
        • FR-Paris cedex 12-SAINTANTOINE
      • Pessac, Frankreich
        • FR-Pessac Cedex-CHUBORDEAUX
      • Poitiers, Frankreich
        • FR-Poitiers-CHUPOITERS
      • Reims, Frankreich
        • FR-Reims-CHREIMS
      • Rennes, Frankreich
        • FR-Rennes cedex 9-CHURENNES
      • Rouen, Frankreich
        • FR-Rouen cedex-BECQUEREL
      • Strasbourg, Frankreich
        • FR-Strasbourg cedex-HAUTEPIERRE
      • Toulouse, Frankreich
        • FR-Toulouse-CHUTOULOUSE
      • Tours, Frankreich
        • FR-Tours cedex-BRETONNEAU
      • Vandœuvre-lès-Nancy, Frankreich
        • FR-Vandoeuvre Les Nancy-CHRUNANCY
      • Villejuif, Frankreich
        • FR-Villejuif-GUSTAVEROUSSY
  • Irland
      • Cork, Irland
        • IE-Cork-CUH
      • Dublin, Irland
        • IE-Dublin 8-STJAMES
      • Dublin, Irland
        • IE-Dublin 9-BEAUMONT
      • Galway, Irland
        • IE-Galway-UHGALWAY
  • Litauen
      • Vilnius, Litauen
        • LT-Vilnius-SANTA
  • Luxemburg
      • Luxembourg, Luxemburg
        • LU-Luxembourg-CHL
  • Niederlande
      • 's-Hertogenbosch, Niederlande
        • NL-Den Bosch-JBZ
      • Amersfoort, Niederlande
        • NL-Amersfoort-MEANDERMC
      • Amsterdam, Niederlande
        • NL-Amsterdam-AMC
      • Amsterdam, Niederlande
        • NL-Amsterdam-OLVG
      • Amsterdam, Niederlande
        • NL-Amsterdam-VUMC
      • Arnhem, Niederlande
        • NL-Arnhem-RIJNSTATE
      • Breda, Niederlande
        • NL-Breda-AMPHIA
      • Delft, Niederlande
        • NL-Delft-RDGG
      • Dordrecht, Niederlande
        • NL-Dordrecht-ASZ
      • Eindhoven, Niederlande
        • NL-Eindhoven-MAXIMAMC
      • Enschede, Niederlande
        • NL-Enschede-MST
      • Groningen, Niederlande
        • NL-Groningen-UMCG
      • Leeuwarden, Niederlande
        • NL-Leeuwarden-MCL
      • Leiden, Niederlande
        • NL-Leiden-LUMC
      • Maastricht, Niederlande
        • NL-Maastricht-MUMC
      • Nieuwegein, Niederlande
        • NL-Nieuwegein-ANTONIUS
      • Nijmegen, Niederlande
        • NL-Nijmegen-RADBOUDUMC
      • Rotterdam, Niederlande
        • NL-Rotterdam-ErasmusMC
      • The Hague, Niederlande
        • NL-Den Haag-HAGA
      • Utrecht, Niederlande
        • NL-Utrecht-UMCUTRECHT
      • Zwolle, Niederlande
        • NL-Zwolle-ISALA
  • Norwegen
      • Bergen, Norwegen
        • NO-Bergen-HELSEBERGEN
      • Oslo, Norwegen
        • NO-Oslo-OSLOUH
      • Stavanger, Norwegen
        • NO-Stavanger-HELSESTAVANGER
      • Tromsø, Norwegen
        • NO-Tromsø-NORTHNOORWEGEN
      • Trondheim, Norwegen
        • NO-Trondheim-STOLAV
  • Schweden
      • Lund, Schweden
        • SE-Lund-SUH
      • Stockholm, Schweden
        • SE-Stockholm-KAROLINSKAHUDDINGE
      • Uppsala, Schweden
        • SE-Uppsala-UPPSALAUH
  • Schweiz
      • Basel, Schweiz
        • CH-Basel-USB
      • Bellinzona, Schweiz
        • CH-Bellinzona-IOSI
      • Bern, Schweiz
        • CH-Bern-INSEL
      • Fribourg, Schweiz
        • CH-Fribourg-HFR
      • Geneva, Schweiz
        • CH-Geneve (14)-HCUGE
      • Lucerne, Schweiz
        • CH-Luzern-LUKS
      • Sankt Gallen, Schweiz
        • CH-St. Gallen-KSSG
      • Zurich, Schweiz
        • CH-Zürich-USZ
  • Spanien
      • Barcelona, Spanien
        • ES-Barcelona-CLINICUB
      • Barcelona, Spanien
        • ES-Barcelona-GERMANTRIALS
      • Barcelona, Spanien
        • ES-Barcelona-ICODURANREYNALS
      • Barcelona, Spanien
        • ES-Barcelona-MUTUATERRASSA
      • Barcelona, Spanien
        • ES-Barcelona-PARCDESALUTMAR
      • Barcelona, Spanien
        • ES-Barcelona-SANTPAU
      • Barcelona, Spanien
        • ES-Barcelona-VHEBRON
      • Girona, Spanien
        • ES-Girona-ICSTRUETA
      • Madrid, Spanien
        • ES-Madrid-CSGREGORIOMARANON
      • Palma, Spanien
        • ES-Palma-SSIB
      • Tarragona, Spanien
        • ES-Tarragona-JOAN
      • Valencia, Spanien
        • ES-Valencia-MALVARROSA
  • Österreich
      • Graz, Österreich
        • AT-Graz-MEDUNIGRAZ
      • Innsbruck, Österreich
        • AT-Innsbruck-IMED
      • Linz, Österreich
        • AT-Linz-ORDENSKLINIKUM
      • Vienna, Österreich
        • AT-Vienna-HANUSCH

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age ≥18 years

  • Newly diagnosed AML or MDS-EB2 defined according to WHO criteria, with a documented IDH1 or IDH2 gene mutation (as determined by the clinical trial assay) at a specific site (IDH1 R132, IDH2 R140, IDH2 R172). AML may be secondary to prior hematological disorders, including MDS, and/or therapy-related (in which prior disease should have been documented to have existed for at least 3 months). Patients may have had previous treatment with hypomethylating agents (HMAs) for MDS. HMAs have to be stopped at least four weeks before registration

  • Patients with dual mutant FLT3 and IDH1 or IDH2 mutations may be enrolled only if, for medical or other reasons, treatment with a FLT3 inhibitor is not considered.

  • Considered to be eligible for intensive chemotherapy.

  • ECOG/WHO performance status ≤ 2

  • Adequate hepatic function as evidenced by:

    • Serum total bilirubin ≤ 2.5 × upper limit of normal (ULN) unless considered due to Gilbert's disease (e.g. a mutation in UGT1A1) (only for patients in IDH2 cohort), or leukemic involvement of the liver - following written approval by the (Co)Principal Investigator.
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement of the liver, following written approval by the Principal Investigator.

  • Adequate renal function as evidenced by creatinine clearance > 40 mL/min based on the Cockroft-Gault formula for glomerular filtration rate (GFR).

  • Able to understand and willing to sign an informed consent form (ICF).

  • Written informed consent

Female patient must either:

o Be of nonchildbearing potential: Postmenopausal (defined as at least 1 year without any menses) prior to screening, or Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)

o Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 6 months after the final study drug administration And have a negative urine or serum pregnancy test at screening And, if heterosexually active, agree to consistently use highly effective* contraception per locally accepted standards in addition to a barrier method starting at screening and throughout the study period and for 6 months after the final study drug administration.

  • Highly effective forms of birth control include:

    • Consistent and correct usage of established hormonal contraceptives that inhibit ovulation,
    • Established intrauterine device (IUD) or intrauterine system (IUS),
    • Bilateral tubal occlusion,
    • Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.)
    • Male is sterile due to a bilateral orchiectomy.
    • Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.

  • List is not all inclusive. Prior to enrollment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control per the requirements of the CTFG Guidance document 'Recommendations related to contraception and pregnancy testing in clinical trials', September 2014 (and any updates thereof) during the protocol defined period.

    • Female patient must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration.

    • Female patient must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.

      • Male patient and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and continue throughout the study period and for 4 months and 1 week after the final study drug administration

      • Male patient must not donate sperm starting at screening and throughout the study period and for 4 months and 1 week after the final study drug administration.

        • Subject agrees not to participate in another interventional study while on treatment

Exclusion Criteria:

  • Prior chemotherapy for AML or MDS-EB2 (with the exception of HMA). Hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts > 30x109/L).

  • Dual IDH1 and IDH2 mutations.

  • Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic variant fusion genes/chromosome translocations.

  • Blast crisis after chronic myeloid leukemia (CML).

  • Known allergy or suspected hypersensitivity to Ivosidenib or Enasidenib and/or any exipients.

  • Taking medications with narrow therapeutic windows with potential interaction with investigational medication (see Appendix I), unless the patient can be transferred to other medications prior to enrolling or unless the medications can be properly monitored during the study.

  • Taking P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) transporter-sensitive substrate medications (see Appendix J) unless the patient can be transferred to other medications within ≥ 5 half-lives prior to administration of ivosidenib or enasidenib, or unless the medications can be properly monitored during the study.

  • Breast feeding at the start of study treatment.

  • Active infection, including hepatitis B or C or HIV infection that is uncontrolled at randomization. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed.

  • Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed:

    • Basal or squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histologic finding of prostate cancer

  • Significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) Class III or IV congestive heart failure (appendix G); myocardial infarction, unstable angina and/or stroke; or left ventricular ejection fraction (LVEF) < 40% by ultrasound or MUGA scan obtained within 28 days prior to the start of study treatment.

  • QTc interval using Fridericia's formula (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure,family history of long QT interval syndrome). Prolonged QTc interval associated with bundle branch block or pacemaking is permitted with written approval of the Principal Investigator.

  • Taking medications that are known to prolong the QT interval (see Appendix K), unless deemed critical and without a suitable alternative. In those cases, they may be administered, but with proper monitoring (see section 10.2, Table 13).

  • Dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.

  • Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening.

  • A known medical history of progressive multifocal leukoencephalopathy (PML).

  • Immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or severe disseminated intravascular coagulation

  • Any other medical condition deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or participate in the study.

  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Arm A: Placebo

Cycle 1: day 1-start cycle 2 | Cycle 2: day 1 - start consolidation treatment | Consolidation treatment: day 1 - start maintenance | Maintenance treatment: day 1- day 730 (2 years) |

The dosage for Placebo for AG-120 (IDH1): 500 mg dose/day

The dosage for Placebo for AG-221 (IDH2): 100mg dose/day
Arzneimittel: Placebo for AG-120

250mg tablets

Arzneimittel: Placebo for AG-221

100mg tablets
Experimental: Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2)

Cycle 1: day 1-start cycle 2 | Cycle 2: day 1 - start consolidation treatment | Consolidation treatment: day 1 - start maintenance | Maintenance treatment: day 1- day 730 (2 years) |

The dosage for AG-120 (IDH1): 500 mg dose/day

The dosage for AG-221 (IDH2): 100mg dose/day
Arzneimittel: AG-120

250mg tablets

Andere Namen:
  • Ivosidenib
Arzneimittel: AG-221

100mg tablets

Andere Namen:
  • Enasidenib

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Event-free survival (EFS)
Zeitfenster: Approximately up to 60 months following first patient enrollment

EFS is defined as the time from randomization to failure to achieve CR or CRi after remission induction, death after achieving CR or CRi or relapse after achieving CR or CRi, whichever occurs first. A patient is said to have failed to achieve CR or CRi after induction therapy, if his/her best response during or at completion of the induction treatment is less than CRi. Patients who achieved CR/CRi after remission induction and are not known to have relapsed or died will be censored at the date of last clinical assessment.
Approximately up to 60 months following first patient enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall survival (OS)
Zeitfenster: Approximately up to 84 months following first patient enrollment

OS is defined as the time from date of randomization to date of death due to any cause. Patients still alive or lost to follow up will be censored at the time they were last known to be alive.
Approximately up to 84 months following first patient enrollment
Relapse-free survival (RFS) after CR/CRi
Zeitfenster: Approximately up to 60 months following first patient enrollment

RFS is defined as time from the date of achievement of CR/CRi until relapse or death from any cause, whichever comes first. Patients still in first CR/CRi and alive or lost to follow up will be censored at the date of last clinical assessment.
Approximately up to 60 months following first patient enrollment
Cumulative incidence of relapse (CIR) after CR/CRi
Zeitfenster: Approximately up to 60 months following first patient enrollment

CIR is measured from the date of achievement of CR/CRi until the date of relapse. Patients not known to have relapsed will be censored on the date of last clinical assessment. Patients who died without relapse will be counted as a competing cause of failure.
Approximately up to 60 months following first patient enrollment
Cumulative incidence of death (CID) after CR/CRi
Zeitfenster: Approximately up to 60 months following first patient enrollment

CID is measured from the date of achievement of CR/CRi until the date of death from any cause. Patients not known to have died will be censored on the date they were last known to be alive. Patients who experienced relapse in CR/CRi will be counted as competing cause of failure.
Approximately up to 60 months following first patient enrollment
Complete remission without minimal residual disease (CRMRD-) rate after induction cycle 2
Zeitfenster: Approximately up to 60 months following first patient enrollment

CRMRD- rate is defined as the percentage of patients who achieved CR or CRi with no evidence of MRD in bone marrow
Approximately up to 60 months following first patient enrollment
Frequency and severity of adverse events according to CTCAE version 5.0
Zeitfenster: Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug

Adverse events will be evaluated using the National Cancer Institute's Common Terminology Criteria for AEs (CTCAE) version 5.0
Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug
CR/CRi rates after induction cycle 1 and 2
Zeitfenster: Approximately up to 60 months following first patient enrollment

CR and CRi are determined by the Investigator based on the European LeukemiaNet (ELN2017) recommended response criteria
Approximately up to 60 months following first patient enrollment
CR/CRi rate after remission induction (i.e., CR or CRi as best response during or at completion of induction therapy)
Zeitfenster: Approximately up to 60 months following first patient enrollment

CR+CRi rate after remission induction is defined as the percentage of patients with best response of CR or CRi during or at completion of induction therapy
Approximately up to 60 months following first patient enrollment
Time to hematopoietic recovery after each chemotherapy treatment cycle
Zeitfenster: Approximately up to 60 months following first patient enrollment

Time to hematopoietic recovery is defined as the time from the start of the cycle until recovery
Approximately up to 60 months following first patient enrollment
EQ-5D-5L visual analogue scale (VAS)
Zeitfenster: At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)

The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today". Each domain has 5 levels. Each level has a 1 digit number expressing the level selected for that dimension. These levels are summed up and the self-rated health is recorded on a 20 cm vertical, visual analogue scale, with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)
EORTC-QLQ-C30 global health status/QoL scale.
Zeitfenster: At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)

The EORTC QLQ-C30 is a 30-item questionnaire that assesses 5 functional subdomains (physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning), 1 global health status, 3 symptom subdomains (fatigue, nausea and vomiting and pain) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Estimate the average of the items that contribute to the scale; this is the raw score. a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Mitarbeiter

University of Ulm

Ermittler

  • Hauptermittler: B.J. Wouters, Erasmus MC / HOVON

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2019

Primärer Abschluss (Geschätzt)

17. April 2027

Studienabschluss (Geschätzt)

19. September 2034

Studienanmeldedaten

Zuerst eingereicht

6. Februar 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Februar 2019

Zuerst gepostet (Tatsächlich)

15. Februar 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. September 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HO150
  • 2018-000451-41 (EudraCT-Nummer)
  • 2018 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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