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IDH1またはIDH2変異を有する新たに診断された急性骨髄性白血病または骨髄異形成症候群EB2患者における、それぞれ集中化学療法に適格な、導入療法および地固め療法と組み合わせたイボシデニブまたはエナシデニブの研究、その後の維持療法 (HOVON150AML)

2026年9月17日 更新者：Stichting Hemato-Oncologie voor Volwassenen Nederland

新たに診断された急性骨髄性白血病または過剰芽球を伴う骨髄異形成症候群の患者における導入療法および地固め療法とその後の維持療法を組み合わせたイボシデニブまたはエナシデニブの第3相、多施設、二重盲検、無作為化、プラセボ対照試験-2、 IDH1またはIDH2突然変異、それぞれ、集中化学療法に適格。

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (推定)

968

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：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
薬：Placebo for AG-120

250mg tablets

薬：Placebo for AG-221

100mg tablets
実験的：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
薬：AG-120

250mg tablets

他の名前：
  • イボシデニブ
薬：AG-221

100mg tablets

他の名前：
  • エナシデニブ

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Event-free survival (EFS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall survival (OS)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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.
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Stichting Hemato-Oncologie voor Volwassenen Nederland

協力者

University of Ulm

捜査官

  • 主任研究者：B.J. Wouters、Erasmus MC / HOVON

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年3月1日

一次修了 (推定)

2027年4月17日

研究の完了 (推定)

2034年9月19日

試験登録日

最初に提出

2019年2月6日

QC基準を満たした最初の提出物

2019年2月12日

最初の投稿 (実際)

2019年2月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年9月17日

最終確認日

2026年3月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • HO150
  • 2018-000451-41 (EudraCT番号)
  • 2018 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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