AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 3HOVON150AMLNCT03839771

A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

A Phase 3 study testing AG-120 and AG-221 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome With Excess Blasts-2, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 181 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AG-120 and AG-221
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
968 participants
Where
181 sitesin 15 countries
Study dates
1 Mar 2019to 19 Sep 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

181 sites in 15 countries.

181 sites in 15 countries

Germany48 sites

  • DE-Bad Saarow-HELIOSBADSAAROW

    Bad Saarow

  • DE-Berlin-CAMPUSBENFRANKLIN

    Berlin

  • DE-Berlin-CAMPUSVIRCHOW

    Berlin

  • DE-Berlin-VIVANTESNEUKOLLN

    Berlin

  • DE-Berlin-VIVANTESURBAN

    Berlin

  • DE-Bochum-RUB

    Bochum

  • DE-Bonn-UNIBONN

    Bonn

  • DE-Braunschweig-KLINIKUMBRAUNSCHWEIG

    Braunschweig

  • DE-Bremen-KBM

    Bremen

  • DE-Dortmund-JOHODORTMUND

    Dortmund

  • DE-Düsseldorf-MEDUNIDUESSELDORF

    Düsseldorf

  • DE-Essen-KEM

    Essen

  • DE-Esslingen-KLINIKUMESSLINGEN

    Esslingen am Neckar

  • DE-Flensburg-MALTESER

    Flensburg

  • DE-Giessen-UKGM

    Giessen

  • DE-Goch-KKLE

    Goch

  • DE-Hamburg-ASKLEPIOSSTGEORG

    Hamburg

  • DE-Hamburg-ASKLEPIOS

    Hamburg

  • DE-Hamburg-UKE

    Hamburg

  • DE-Hamm-EVKHAMM

    Hamm

  • DE-Hanau-KLINIKUMHANAU

    Hanau

  • DE-Hannover-MHHANNOVER

    Hanover

  • DE-Hannover-SILOAHKRH

    Hanover

  • DE-Herne-MARIENHOSPITALHERNE

    Herne

  • DE-Homburg-UNIKLINIKSAARLAND

    Homburg

  • DE-Karlsruhe-KLINIKUMKARLSRUHE

    Karlsruhe

  • DE-Lebach-CARITASKHLEBACH

    Lebach

  • DE-Lemgo-KLINIKUMLIPPE

    Lemgo

  • DE-Luedenscheid-KLINIKUMLUEDENSCHEID

    Lüdenscheid

  • DE-Ludwigshafen-KLILU

    Ludwigshafen

  • DE-Magdeburg-OVGU

    Magdeburg

  • DE-Mainz-KLINKUNIMAINZ

    Mainz

  • DE-Mainz-UNIMEDIZINMAINZ

    Mainz

  • DE-Meschede-HOCHSAUERLAND

    Meschede

  • DE-Minden-MUEHLENKREISKLINKEN

    Minden

  • DE-München-IRZTUM

    München

  • DE-München-MEDUNIMUNCHIN

    München

  • DE-Offenburg-ORTENAUKLINIKUM

    Offenburg

  • DE-Oldenburg-KLINIKUMOLDENBURG

    Oldenburg

  • DE-Passau-KLINIKUMPASSAU

    Passau

  • DE-Stuttgart-DIAKSTUTTGART

    Stuttgart

  • DE-Stuttgart-KLINIKUMSTUTTGART

    Stuttgart

  • DE-Traunstein-TSSOB

    Traunstein

  • DE-Trier-MUTTERHAUS

    Trier

  • DE-Tübingen-MEDUNITUEBINGEN

    Tübingen

  • DE-Ulm-UNIKLINKULM

    Ulm

  • DE-Villingen-Schwenningen-SBKVS

    Villingen-Schwenningen

  • DE-Wuppertal-HELIOSGESUNDHEIT

    Wuppertal

Other trials in Germany

France37 sites

  • FR-Amiens-CHUAMIENS

    Amiens

  • FR-Angers-CHUANGERS

    Angers

  • FR-Argenteuil-CHARGENTEUIL

    Argenteuil

  • FR-Bayonne-CHCOTEBASQUE

    Bayonne

  • FR-Besançon Cedex-JEANMINJOZ

    Besançon

  • FR-Bobigny-AVICENNE

    Bobigny

  • FR-Chambery-CHMETROPOLESAVOIE

    Chambéry

  • FR-Le Chesnay cedex-CHVERSAILLES

    Chesnay

  • FR-Clamart-HIAPERCY

    Clamart

  • FR-Clermont-Ferrand-ESTAING

    Clermont-Ferrand

  • FR-Créteil cedex-CHUMONDOR

    Créteil

  • FR-Grenoble cedex 9-CHUGRENOBLE

    Grenoble

  • FR-Lens-CHLENS

    Lens

  • FR-Lille-CHULILLE

    Lille

  • FR-Limoges-CHULIMOGES

    Limoges

  • FR-Lyon Pierre Benite cedex-LYONSUD

    Lyon

  • FR-Lyon-LEONBERARD

    Lyon

  • FR-Marseille-IPC

    Marseille

  • FR-Montpellier-STELOI

    Montpellier

  • FR-Mulhouse-GHRMSA

    Mulhouse

  • FR-Nantes-CHUNANTES

    Nantes

  • FR-Nice-CAL

    Nice

  • FR-Nice-LARCHET

    Nice

  • FR-Orléans-CHORLEANS

    Orléans

  • FR-Paris cedex 10-SAINTLOUIS

    Paris

  • FR-Paris cedex 12-SAINTANTOINE

    Paris

  • FR-Paris cedex 15-NECKER

    Paris

  • FR-Pessac Cedex-CHUBORDEAUX

    Pessac

  • FR-Poitiers-CHUPOITERS

    Poitiers

  • FR-Reims-CHREIMS

    Reims

  • FR-Rennes cedex 9-CHURENNES

    Rennes

  • FR-Rouen cedex-BECQUEREL

    Rouen

  • FR-Strasbourg cedex-HAUTEPIERRE

    Strasbourg

  • FR-Toulouse-CHUTOULOUSE

    Toulouse

  • FR-Tours cedex-BRETONNEAU

    Tours

  • FR-Vandoeuvre Les Nancy-CHRUNANCY

    Vandœuvre-lès-Nancy

  • FR-Villejuif-GUSTAVEROUSSY

    Villejuif

Other trials in France

Australia21 sites

  • AU-Adelaide-FLINDERS

    Adelaide

  • AU-Adelaide-RAH

    Adelaide

  • AU-Brisbane-PAH

    Brisbane

  • AU-Camperdown-RPA

    Camperdown

  • AU-Canberra-CANBERRAHOSPITAL

    Canberra

  • AU-Douglas-TOWNSVILLE

    Douglas

  • AU-Hobart TAS-RHOBART

    Hobart

  • AU-Launceston TAS-LAUNCESTON

    Launceston

  • AU-Melbourne-ALFRED

    Melbourne

  • AU-Melbourne-AUSTIN

    Melbourne

  • AU-Melbourne-MONASH

    Melbourne

  • AU-Melbourne-RMELBOURNE

    Melbourne

  • AU-Melbourne-SVHM

    Melbourne

  • AU-Perth-FSH

    Perth

  • AU-Perth-RPH

    Perth

  • AU-Perth-SCGH

    Perth

  • AU-Sydney-CONCORD

    Sydney

  • AU-Sydney-RNSH

    Sydney

  • AU-Sydney-SVHS

    Sydney

  • AU-Sydney-WSAH

    Sydney

  • AU-Waratah-CALVARYMATER

    Waratah

Other trials in Australia

Netherlands21 sites

  • NL-Den Bosch-JBZ

    's-Hertogenbosch

  • NL-Amersfoort-MEANDERMC

    Amersfoort

  • NL-Amsterdam-AMC

    Amsterdam

  • NL-Amsterdam-OLVG

    Amsterdam

  • NL-Amsterdam-VUMC

    Amsterdam

  • NL-Arnhem-RIJNSTATE

    Arnhem

  • NL-Breda-AMPHIA

    Breda

  • NL-Delft-RDGG

    Delft

  • NL-Dordrecht-ASZ

    Dordrecht

  • NL-Eindhoven-MAXIMAMC

    Eindhoven

  • NL-Enschede-MST

    Enschede

  • NL-Groningen-UMCG

    Groningen

  • NL-Leeuwarden-MCL

    Leeuwarden

  • NL-Leiden-LUMC

    Leiden

  • NL-Maastricht-MUMC

    Maastricht

  • NL-Nieuwegein-ANTONIUS

    Nieuwegein

  • NL-Nijmegen-RADBOUDUMC

    Nijmegen

  • NL-Rotterdam-ErasmusMC

    Rotterdam

  • NL-Den Haag-HAGA

    The Hague

  • NL-Utrecht-UMCUTRECHT

    Utrecht

  • NL-Zwolle-ISALA

    Zwolle

Other trials in Netherlands

Belgium13 sites

  • BE-Antwerpen-ZNASTUIVENBERG

    Antwerp

  • BE-Brugge-AZBRUGGE

    Bruges

  • BE-Brussel-BORDET

    Brussels

  • BE-Brussel-UZBRUSSEL

    Brussels

  • BE-Bruxelles-STLUC

    Brussels

  • BE-Gent-UZGENT

    Ghent

  • BE-Haine-Saint-Paul-JOLIMONT

    Haine-Saint-Paul

  • BE-Hasselt-VIRGAJESSE

    Hasselt

  • BE-Leuven-UZLEUVEN

    Leuven

  • BE-Liege-CHRCITADELLE

    Liège

  • BE-Liege-CHULIEGE

    Liège

  • BE-Roeselare-AZDELTA

    Roeselare

  • BE-Yvoir-MONTGODINNE

    Yvoir

Other trials in Belgium

Spain12 sites

  • ES-Barcelona-CLINICUB

    Barcelona

  • ES-Barcelona-GERMANTRIALS

    Barcelona

  • ES-Barcelona-ICODURANREYNALS

    Barcelona

  • ES-Barcelona-MUTUATERRASSA

    Barcelona

  • ES-Barcelona-PARCDESALUTMAR

    Barcelona

  • ES-Barcelona-SANTPAU

    Barcelona

  • ES-Barcelona-VHEBRON

    Barcelona

  • ES-Girona-ICSTRUETA

    Girona

  • ES-Madrid-CSGREGORIOMARANON

    Madrid

  • ES-Palma-SSIB

    Palma

  • ES-Tarragona-JOAN

    Tarragona

  • ES-Valencia-MALVARROSA

    Valencia

Other trials in Spain

Switzerland8 sites

  • CH-Basel-USB

    Basel

  • CH-Bellinzona-IOSI

    Bellinzona

  • CH-Bern-INSEL

    Bern

  • CH-Fribourg-HFR

    Fribourg

  • CH-Geneve (14)-HCUGE

    Geneva

  • CH-Luzern-LUKS

    Lucerne

  • CH-St. Gallen-KSSG

    Sankt Gallen

  • CH-Zürich-USZ

    Zurich

Other trials in Switzerland

Norway5 sites

  • NO-Bergen-HELSEBERGEN

    Bergen

  • NO-Oslo-OSLOUH

    Oslo

  • NO-Stavanger-HELSESTAVANGER

    Stavanger

  • NO-Tromsø-NORTHNOORWEGEN

    Tromsø

  • NO-Trondheim-STOLAV

    Trondheim

Other trials in Norway

Austria4 sites

  • AT-Graz-MEDUNIGRAZ

    Graz

  • AT-Innsbruck-IMED

    Innsbruck

  • AT-Linz-ORDENSKLINIKUM

    Linz

  • AT-Vienna-HANUSCH

    Vienna

Other trials in Austria

Ireland4 sites

  • IE-Cork-CUH

    Cork

  • IE-Dublin 8-STJAMES

    Dublin

  • IE-Dublin 9-BEAUMONT

    Dublin

  • IE-Galway-UHGALWAY

    Galway

Other trials in Ireland

Sweden3 sites

  • SE-Lund-SUH

    Lund

  • SE-Stockholm-KAROLINSKAHUDDINGE

    Stockholm

  • SE-Uppsala-UPPSALAUH

    Uppsala

Other trials in Sweden

Finland2 sites

  • FI-Helsinki-HUS

    Helsinki

  • FI-Tampere-TAYS

    Tampere

Other trials in Finland

Estonia1 site

  • EE-Tartu-TARTU

    Tartu

Other trials in Estonia

Lithuania1 site

  • LT-Vilnius-SANTA

    Vilnius

Other trials in Lithuania

Luxembourg1 site

  • LU-Luxembourg-CHL

    Luxembourg

Other trials in Luxembourg

About this study

Official title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy.

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.

Being tested
AG-120, Placebo for AG-120, AG-221, Placebo for AG-221
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AG-120Drug

    Also called Ivosidenib

    250mg tablets

  • Placebo for AG-120Drug

    250mg tablets

  • AG-221Drug

    Also called Enasidenib

    100mg tablets

  • Placebo for AG-221Drug

    100mg tablets

Study groups in NCT03839771
Study groupRoleWhat they receive
Arm A: PlaceboPlacebo comparatorCycle 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
Receives: Drug: Placebo for AG-120; Drug: Placebo for AG-221
Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2)ExperimentalCycle 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
Receives: Drug: AG-120; Drug: AG-221

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

    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.

    Measured: Approximately up to 60 months following first patient enrollment

Secondary outcomes (11)

  1. Overall survival (OS)

    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.

    Measured: Approximately up to 84 months following first patient enrollment

  2. Relapse-free survival (RFS) after CR/CRi

    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.

    Measured: Approximately up to 60 months following first patient enrollment

  3. Cumulative incidence of relapse (CIR) after CR/CRi

    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.

    Measured: Approximately up to 60 months following first patient enrollment

  4. Cumulative incidence of death (CID) after CR/CRi

    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.

    Measured: Approximately up to 60 months following first patient enrollment

  5. Complete remission without minimal residual disease (CRMRD-) rate after induction cycle 2

    CRMRD- rate is defined as the percentage of patients who achieved CR or CRi with no evidence of MRD in bone marrow

    Measured: Approximately up to 60 months following first patient enrollment

  6. Frequency and severity of adverse events according to CTCAE version 5.0

    Adverse events will be evaluated using the National Cancer Institute's Common Terminology Criteria for AEs (CTCAE) version 5.0

    Measured: Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug

  7. CR/CRi rates after induction cycle 1 and 2

    CR and CRi are determined by the Investigator based on the European LeukemiaNet (ELN2017) recommended response criteria

    Measured: Approximately up to 60 months following first patient enrollment

  8. CR/CRi rate after remission induction (i.e., CR or CRi as best response during or at completion of induction therapy)

    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

    Measured: Approximately up to 60 months following first patient enrollment

  9. Time to hematopoietic recovery after each chemotherapy treatment cycle

    Time to hematopoietic recovery is defined as the time from the start of the cycle until recovery

    Measured: Approximately up to 60 months following first patient enrollment

  10. EQ-5D-5L visual analogue scale (VAS)

    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'.

    Measured: 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)

  11. EORTC-QLQ-C30 global health status/QoL scale.

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start1 Mar 2019
  3. Primary completion17 Apr 2027 (estimated)
  4. Study completion19 Sep 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
968 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03839771
Sponsor's protocol ID
HO150
Other IDs
2018-000451-41, 2018
Acronym
HOVON150AML
Status last verified
Mar 2026
First submitted
6 Feb 2019
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AG-120 and AG-221 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome With Excess Blasts-2, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 181 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 181 sites in Germany, France, Australia, Netherlands, Belgium and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS) (time frame: Approximately up to 60 months following first patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03839771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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