HOVON150AML: 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

Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland (Other)
Overall Status
Recruiting
CT.gov ID
NCT03839771
Collaborator
Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG) (Other)
968
182
2
168
5.3
0

Study Details

Study Description

Brief 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). 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
968 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 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

Drug: Placebo for AG-120
250mg tablets

Drug: 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

Drug: AG-120
250mg tablets
Other Names:
  • Ivosidenib
  • Drug: AG-221
    100mg tablets
    Other Names:
  • Enasidenib
  • Outcome Measures

    Primary Outcome Measures

    1. Event-free survival (EFS) [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.

    Secondary Outcome Measures

    1. Overall survival (OS) [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.

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

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

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

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

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

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

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

    9. Time to hematopoietic recovery after each chemotherapy treatment cycle [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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AU-Adelaide-FLINDERS Adelaide Australia
    2 AU-Adelaide-RAH Adelaide Australia
    3 AU-Brisbane-PAH Brisbane Australia
    4 AU-Camperdown-RPA Camperdown Australia
    5 AU-Canberra-CANBERRAHOSPITAL Canberra Australia
    6 AU-Douglas-TOWNSVILLE Douglas Australia
    7 AU-Hobart TAS-RHOBART Hobart Australia
    8 AU-Launceston TAS-LAUNCESTON Launceston Australia
    9 AU-Melbourne-ALFRED Melbourne Australia
    10 AU-Melbourne-AUSTIN Melbourne Australia
    11 AU-Melbourne-MONASH Melbourne Australia
    12 AU-Melbourne-RMELBOURNE Melbourne Australia
    13 AU-Melbourne-SVHM Melbourne Australia
    14 AU-Perth-FSH Perth Australia
    15 AU-Perth-RPH Perth Australia
    16 AU-Perth-SCGH Perth Australia
    17 AU-Sydney-CONCORD Sydney Australia
    18 AU-Sydney-RNSH Sydney Australia
    19 AU-Sydney-SVHS Sydney Australia
    20 AU-Sydney-WSAH Sydney Australia
    21 AU-Waratah-CALVARYMATER Waratah Australia
    22 AT-Graz-MEDUNIGRAZ Graz Austria
    23 AT-Innsbruck-IMED Innsbruck Austria
    24 AT-Linz-ORDENSKLINIKUM Linz Austria
    25 AT-Vienna-HANUSCH Vienna Austria
    26 BE-Antwerpen-ZNASTUIVENBERG Antwerpen Belgium
    27 BE-Brugge-AZBRUGGE Brugge Belgium
    28 BE-Brussel-BORDET Brussels Belgium
    29 BE-Brussel-UZBRUSSEL Brussels Belgium
    30 BE-Bruxelles-STLUC Brussels Belgium
    31 BE-Gent-UZGENT Gent Belgium
    32 BE-Haine-Saint-Paul-JOLIMONT Haine-Saint-Paul Belgium
    33 BE-Hasselt-VIRGAJESSE Hasselt Belgium
    34 BE-Leuven-UZLEUVEN Leuven Belgium
    35 BE-Liege-CHRCITADELLE Liège Belgium
    36 BE-Liege-CHULIEGE Liège Belgium
    37 BE-Roeselare-AZDELTA Roeselare Belgium
    38 BE-Yvoir-MONTGODINNE Yvoir Belgium
    39 EE-Tartu-TARTU Tartu Estonia
    40 FI-Helsinki-HUS Helsinki Finland
    41 FI-Tampere-TAYS Tampere Finland
    42 FR-Amiens-CHUAMIENS Amiens France
    43 FR-Angers-CHUANGERS Angers France
    44 FR-Argenteuil-CHARGENTEUIL Argenteuil France
    45 FR-Bayonne-CHCOTEBASQUE Bayonne France
    46 FR-Besançon Cedex-JEANMINJOZ Besançon France
    47 FR-Bobigny-AVICENNE Bobigny France
    48 FR-Chambery-CHMETROPOLESAVOIE Chambéry France
    49 FR-Le Chesnay cedex-CHVERSAILLES Chesnay France
    50 FR-Clamart-HIAPERCY Clamart France
    51 FR-Clermont-Ferrand-ESTAING Clermont-Ferrand France
    52 FR-Créteil cedex-CHUMONDOR Créteil France
    53 FR-Grenoble cedex 9-CHUGRENOBLE Grenoble cedex 9 France
    54 FR-Lens-CHLENS Lens France
    55 FR-Lille-CHULILLE Lille France
    56 FR-Limoges-CHULIMOGES Limoges France
    57 FR-Lyon Pierre Benite cedex-LYONSUD Lyon France
    58 FR-Lyon-LEONBERARD Lyon France
    59 FR-Marseille-IPC Marseille France
    60 FR-Montpellier-STELOI Montpellier France
    61 FR-Mulhouse-GHRMSA Mulhouse France
    62 FR-Nantes-CHUNANTES Nantes France
    63 FR-Nice-CAL Nice France
    64 FR-Nice-LARCHET Nice France
    65 FR-Orléans-CHORLEANS Orléans France
    66 FR-Paris cedex 10-SAINTLOUIS Paris France
    67 FR-Paris cedex 12-SAINTANTOINE Paris France
    68 FR-Paris cedex 15-NECKER Paris France
    69 FR-Pessac Cedex-CHUBORDEAUX Pessac France
    70 FR-Poitiers-CHUPOITERS Poitiers France
    71 FR-Reims-CHREIMS Reims France
    72 FR-Rennes cedex 9-CHURENNES Rennes France
    73 FR-Rouen cedex-BECQUEREL Rouen France
    74 FR-Strasbourg cedex-HAUTEPIERRE Strasbourg France
    75 FR-Toulouse-CHUTOULOUSE Toulouse France
    76 FR-Tours cedex-BRETONNEAU Tours France
    77 FR-Vandoeuvre Les Nancy-CHRUNANCY Vandœuvre-lès-Nancy France
    78 FR-Villejuif-GUSTAVEROUSSY Villejuif France
    79 DE-Bad Saarow-HELIOSBADSAAROW Bad Saarow Germany
    80 DE-Berlin-CAMPUSBENFRANKLIN Berlin Germany
    81 DE-Berlin-CAMPUSVIRCHOW Berlin Germany
    82 DE-Berlin-VIVANTESNEUKOLLN Berlin Germany
    83 DE-Berlin-VIVANTESURBAN Berlin Germany
    84 DE-Bochum-RUB Bochum Germany
    85 DE-Bonn-UNIBONN Bonn Germany
    86 DE-Braunschweig-KLINIKUMBRAUNSCHWEIG Braunschweig Germany
    87 DE-Bremen-KBM Bremen Germany
    88 DE-Dortmund-JOHODORTMUND Dortmund Germany
    89 DE-Düsseldorf-MEDUNIDUESSELDORF Düsseldorf Germany
    90 DE-Essen-KEM Essen Germany
    91 DE-Esslingen-KLINIKUMESSLINGEN Esslingen Germany
    92 DE-Flensburg-MALTESER Flensburg Germany
    93 DE-Giessen-UKGM Gießen Germany
    94 DE-Goch-KKLE Goch Germany
    95 DE-Hamburg-ASKLEPIOSSTGEORG Hamburg Germany
    96 DE-Hamburg-ASKLEPIOS Hamburg Germany
    97 DE-Hamburg-UKE Hamburg Germany
    98 DE-Hamm-EVKHAMM Hamm Germany
    99 DE-Hanau-KLINIKUMHANAU Hanau Germany
    100 DE-Hannover-MHHANNOVER Hannover Germany
    101 DE-Hannover-SILOAHKRH Hannover Germany
    102 DE-Herne-MARIENHOSPITALHERNE Herne Germany
    103 DE-Homburg-UNIKLINIKSAARLAND Homburg Germany
    104 DE-Karlsruhe-KLINIKUMKARLSRUHE Karlsruhe Germany
    105 DE-Lebach-CARITASKHLEBACH Lebach Germany
    106 DE-Lemgo-KLINIKUMLIPPE Lemgo Germany
    107 DE-Ludwigshafen-KLILU Ludwigshafen Germany
    108 DE-Luedenscheid-KLINIKUMLUEDENSCHEID Lüdenscheid Germany
    109 DE-Magdeburg-OVGU Magdeburg Germany
    110 DE-Mainz-KLINKUNIMAINZ Mainz Germany
    111 DE-Mainz-UNIMEDIZINMAINZ Mainz Germany
    112 DE-Meschede-HOCHSAUERLAND Meschede Germany
    113 DE-Minden-MUEHLENKREISKLINKEN Minden Germany
    114 DE-München-IRZTUM München Germany
    115 DE-München-MEDUNIMUNCHIN München Germany
    116 DE-Offenburg-ORTENAUKLINIKUM Offenburg Germany
    117 DE-Oldenburg-KLINIKUMOLDENBURG Oldenburg Germany
    118 DE-Passau-KLINIKUMPASSAU Passau Germany
    119 DE-Stuttgart-DIAKSTUTTGART Stuttgart Germany
    120 DE-Stuttgart-KLINIKUMSTUTTGART Stuttgart Germany
    121 DE-Traunstein-TSSOB Traunstein Germany
    122 DE-Trier-MUTTERHAUS Trier Germany
    123 DE-Tübingen-MEDUNITUEBINGEN Tübingen Germany
    124 DE-Ulm-UNIKLINKULM Ulm Germany
    125 DE-Villingen-Schwenningen-SBKVS Villingen-Schwenningen Germany
    126 DE-Wuppertal-HELIOSGESUNDHEIT Wuppertal Germany
    127 IE-Cork-CUH Cork Ireland
    128 IE-Dublin 8-STJAMES Dublin Ireland
    129 IE-Dublin 9-BEAUMONT Dublin Ireland
    130 IE-Galway-UHGALWAY Galway Ireland
    131 LT-Vilnius-SANTA Vilnius Lithuania
    132 LU-Luxembourg-CHL Luxembourg Luxembourg
    133 NL-Amersfoort-MEANDERMC Amersfoort Netherlands
    134 NL-Amsterdam-AMC Amsterdam Netherlands
    135 NL-Amsterdam-OLVG Amsterdam Netherlands
    136 NL-Amsterdam-VUMC Amsterdam Netherlands
    137 NL-Arnhem-RIJNSTATE Arnhem Netherlands
    138 NL-Breda-AMPHIA Breda Netherlands
    139 NL-Delft-RDGG Delft Netherlands
    140 NL-Den Bosch-JBZ Den Bosch Netherlands
    141 NL-Den Haag-HAGA Den Haag Netherlands
    142 NL-Dordrecht-ASZ Dordrecht Netherlands
    143 NL-Eindhoven-MAXIMAMC Eindhoven Netherlands
    144 NL-Enschede-MST Enschede Netherlands
    145 NL-Groningen-UMCG Groningen Netherlands
    146 NL-Leeuwarden-MCL Leeuwarden Netherlands
    147 NL-Leiden-LUMC Leiden Netherlands
    148 NL-Maastricht-MUMC Maastricht Netherlands
    149 NL-Nieuwegein-ANTONIUS Nieuwegein Netherlands
    150 NL-Nijmegen-RADBOUDUMC Nijmegen Netherlands
    151 NL-Rotterdam-ErasmusMC Rotterdam Netherlands
    152 NL-Utrecht-UMCUTRECHT Utrecht Netherlands
    153 NL-Zwolle-ISALA Zwolle Netherlands
    154 NO-Bergen-HELSEBERGEN Bergen Norway
    155 NO-Oslo-OSLOUH Oslo Norway
    156 NO-Stavanger-HELSESTAVANGER Stavanger Norway
    157 NO-Tromsø-NORTHNOORWEGEN Tromsø Norway
    158 NO-Trondheim-STOLAV Trondheim Norway
    159 ES-Barcelona-CLINICUB Barcelona Spain
    160 ES-Barcelona-GERMANTRIALS Barcelona Spain
    161 ES-Barcelona-ICODURANREYNALS Barcelona Spain
    162 ES-Barcelona-MUTUATERRASSA Barcelona Spain
    163 ES-Barcelona-PARCDESALUTMAR Barcelona Spain
    164 ES-Barcelona-SANTPAU Barcelona Spain
    165 ES-Barcelona-VHEBRON Barcelona Spain
    166 ES-Girona-ICSTRUETA Girona Spain
    167 ES-Madrid-CSGREGORIOMARANON Madrid Spain
    168 ES-Palma-SSIB Palma Spain
    169 ES-Tarragona-JOAN Tarragona Spain
    170 ES-Valencia-MALVARROSA Valencia Spain
    171 SE-Lund-SUH Lund Sweden
    172 SE-Stockholm-KAROLINSKAHUDDINGE Stockholm Sweden
    173 SE-Uppsala-UPPSALAUH Uppsala Sweden
    174 CH-Basel-USB Basel Switzerland
    175 CH-Bellinzona-IOSI Bellinzona Switzerland
    176 CH-Bern-INSEL Bern Switzerland
    177 CH-Fribourg-HFR Fribourg Switzerland
    178 CH-Geneve (14)-HCUGE Geneve Switzerland
    179 CH-Lausanne-CHUV Lausanne Switzerland
    180 CH-Luzern-LUKS Luzern Switzerland
    181 CH-St. Gallen-KSSG Saint Gallen Switzerland
    182 CH-Zürich-USZ Zürich Switzerland

    Sponsors and Collaborators

    • Stichting Hemato-Oncologie voor Volwassenen Nederland
    • Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)

    Investigators

    • Principal Investigator: B.J. Wouters, Erasmus MC / HOVON

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Stichting Hemato-Oncologie voor Volwassenen Nederland
    ClinicalTrials.gov Identifier:
    NCT03839771
    Other Study ID Numbers:
    • HO150
    • 2018-000451-41
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 1, 2021