Clinical trial NCT03839771: 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
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome With Excess Blasts-2
Lead sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
Sponsor class: OTHER
Collaborators: name: Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)
First posted: 2019-02-15
Enrollment: 968
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: Approximately up to 60 months following first patient enrollment
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Approximately up to 84 months following first patient enrollment
measure: Relapse-free survival (RFS) after CR/CRi
timeFrame: Approximately up to 60 months following first patient enrollment
measure: Cumulative incidence of relapse (CIR) after CR/CRi
timeFrame: Approximately up to 60 months following first patient enrollment
measure: Cumulative incidence of death (CID) after CR/CRi
timeFrame: Approximately up to 60 months following first patient enrollment
measure: Complete remission without minimal residual disease (CRMRD-) rate after induction cycle 2
timeFrame: Approximately up to 60 months following first patient enrollment
measure: Frequency and severity of adverse events according to CTCAE version 5.0
timeFrame: Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug
measure: CR/CRi rates after induction cycle 1 and 2
timeFrame: Approximately up to 60 months following first patient enrollment
measure: CR/CRi rate after remission induction (i.e., CR or CRi as best response during or at completion of induction therapy)
timeFrame: Approximately up to 60 months following first patient enrollment
measure: Time to hematopoietic recovery after each chemotherapy treatment cycle
timeFrame: Approximately up to 60 months following first patient enrollment
measure: EQ-5D-5L visual analogue scale (VAS)
timeFrame: 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)
measure: EORTC-QLQ-C30 global health status/QoL scale.
timeFrame: 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)
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: AU-Adelaide-FLINDERS
city: Adelaide
country: Australia
facility: AU-Adelaide-RAH
city: Brisbane
country: Australia
facility: AU-Brisbane-PAH
city: Camperdown
country: Australia
facility: AU-Camperdown-RPA
city: Canberra
country: Australia
facility: AU-Canberra-CANBERRAHOSPITAL
city: Douglas
country: Australia
facility: AU-Douglas-TOWNSVILLE
city: Hobart
country: Australia
facility: AU-Hobart TAS-RHOBART
city: Launceston
country: Australia
facility: AU-Launceston TAS-LAUNCESTON
city: Melbourne
country: Australia
facility: AU-Melbourne-ALFRED
city: Melbourne
country: Australia
facility: AU-Melbourne-AUSTIN
city: Melbourne
country: Australia
facility: AU-Melbourne-MONASH
city: Melbourne
country: Australia
facility: AU-Melbourne-RMELBOURNE
city: Melbourne
country: Australia
facility: AU-Melbourne-SVHM
city: Perth
country: Australia
facility: AU-Perth-FSH
city: Perth
country: Australia
facility: AU-Perth-RPH
city: Perth
country: Australia
facility: AU-Perth-SCGH
city: Sydney
country: Australia
facility: AU-Sydney-CONCORD
city: Sydney
country: Australia
facility: AU-Sydney-RNSH
city: Sydney
country: Australia
facility: AU-Sydney-SVHS
city: Sydney
country: Australia
facility: AU-Sydney-WSAH
city: Waratah
country: Australia
facility: AU-Waratah-CALVARYMATER
city: Graz
country: Austria
facility: AT-Graz-MEDUNIGRAZ
city: Innsbruck
country: Austria
facility: AT-Innsbruck-IMED
city: Linz
country: Austria
facility: AT-Linz-ORDENSKLINIKUM
city: Vienna
country: Austria
facility: AT-Vienna-HANUSCH
city: Antwerpen
country: Belgium
facility: BE-Antwerpen-ZNASTUIVENBERG
city: Brugge
country: Belgium
facility: BE-Brugge-AZBRUGGE
city: Brussels
country: Belgium
facility: BE-Brussel-BORDET
city: Brussels
country: Belgium
facility: BE-Brussel-UZBRUSSEL
city: Brussels
country: Belgium
facility: BE-Bruxelles-STLUC
city: Gent
country: Belgium
facility: BE-Gent-UZGENT
city: Haine-Saint-Paul
country: Belgium
facility: BE-Haine-Saint-Paul-JOLIMONT
city: Hasselt
country: Belgium
facility: BE-Hasselt-VIRGAJESSE
city: Leuven
country: Belgium
facility: BE-Leuven-UZLEUVEN
city: Liège
country: Belgium
facility: BE-Liege-CHRCITADELLE
city: Liège
country: Belgium
facility: BE-Liege-CHULIEGE
city: Roeselare
country: Belgium
facility: BE-Roeselare-AZDELTA
city: Yvoir
country: Belgium
facility: BE-Yvoir-MONTGODINNE
city: Tartu
country: Estonia
facility: EE-Tartu-TARTU
city: Helsinki
country: Finland
facility: FI-Helsinki-HUS
city: Tampere
country: Finland
facility: FI-Tampere-TAYS
city: Amiens
country: France
facility: FR-Amiens-CHUAMIENS
city: Angers
country: France
facility: FR-Angers-CHUANGERS
city: Argenteuil
country: France
facility: FR-Argenteuil-CHARGENTEUIL
city: Bayonne
country: France
facility: FR-Bayonne-CHCOTEBASQUE
city: Besançon
country: France
facility: FR-Besançon Cedex-JEANMINJOZ
city: Bobigny
country: France
facility: FR-Bobigny-AVICENNE
city: Chambéry
country: France
facility: FR-Chambery-CHMETROPOLESAVOIE
city: Chesnay
country: France
facility: FR-Le Chesnay cedex-CHVERSAILLES
city: Clamart
country: France
facility: FR-Clamart-HIAPERCY
city: Clermont-Ferrand
country: France
facility: FR-Clermont-Ferrand-ESTAING
city: Créteil
country: France
facility: FR-Créteil cedex-CHUMONDOR
city: Grenoble cedex 9
country: France
facility: FR-Grenoble cedex 9-CHUGRENOBLE
city: Lens
country: France
facility: FR-Lens-CHLENS
city: Lille
country: France
facility: FR-Lille-CHULILLE
city: Limoges
country: France
facility: FR-Limoges-CHULIMOGES
city: Lyon
country: France
facility: FR-Lyon Pierre Benite cedex-LYONSUD
city: Lyon
country: France
facility: FR-Lyon-LEONBERARD
city: Marseille
country: France
facility: FR-Marseille-IPC
city: Montpellier
country: France
facility: FR-Montpellier-STELOI
city: Mulhouse
country: France
facility: FR-Mulhouse-GHRMSA
city: Nantes
country: France
facility: FR-Nantes-CHUNANTES
city: Nice
country: France
facility: FR-Nice-CAL
city: Nice
country: France
facility: FR-Nice-LARCHET
city: Orléans
country: France
facility: FR-Orléans-CHORLEANS
city: Paris
country: France
facility: FR-Paris cedex 10-SAINTLOUIS
city: Paris
country: France
facility: FR-Paris cedex 12-SAINTANTOINE
city: Paris
country: France
facility: FR-Paris cedex 15-NECKER
city: Pessac
country: France
facility: FR-Pessac Cedex-CHUBORDEAUX
city: Poitiers
country: France
facility: FR-Poitiers-CHUPOITERS
city: Reims
country: France
facility: FR-Reims-CHREIMS
city: Rennes
country: France
facility: FR-Rennes cedex 9-CHURENNES
city: Rouen
country: France
facility: FR-Rouen cedex-BECQUEREL
city: Strasbourg
country: France
facility: FR-Strasbourg cedex-HAUTEPIERRE
city: Toulouse
country: France
facility: FR-Toulouse-CHUTOULOUSE
city: Tours
country: France
facility: FR-Tours cedex-BRETONNEAU
city: Vandœuvre-lès-Nancy
country: France
facility: FR-Vandoeuvre Les Nancy-CHRUNANCY
city: Villejuif
country: France
facility: FR-Villejuif-GUSTAVEROUSSY
city: Bad Saarow
country: Germany
facility: DE-Bad Saarow-HELIOSBADSAAROW
city: Berlin
country: Germany
facility: DE-Berlin-CAMPUSBENFRANKLIN
city: Berlin
country: Germany
facility: DE-Berlin-CAMPUSVIRCHOW
city: Berlin
country: Germany
facility: DE-Berlin-VIVANTESNEUKOLLN
city: Berlin
country: Germany
facility: DE-Berlin-VIVANTESURBAN
city: Bochum
country: Germany
facility: DE-Bochum-RUB
city: Bonn
country: Germany
facility: DE-Bonn-UNIBONN
city: Braunschweig
country: Germany
facility: DE-Braunschweig-KLINIKUMBRAUNSCHWEIG
city: Bremen
country: Germany
facility: DE-Bremen-KBM
city: Dortmund
country: Germany
facility: DE-Dortmund-JOHODORTMUND
city: Düsseldorf
country: Germany
facility: DE-Düsseldorf-MEDUNIDUESSELDORF
city: Essen
country: Germany
facility: DE-Essen-KEM
city: Esslingen
country: Germany
facility: DE-Esslingen-KLINIKUMESSLINGEN
city: Flensburg
country: Germany
facility: DE-Flensburg-MALTESER
city: Gießen
country: Germany
facility: DE-Giessen-UKGM
city: Goch
country: Germany
facility: DE-Goch-KKLE
city: Hamburg
country: Germany
facility: DE-Hamburg-ASKLEPIOSSTGEORG
city: Hamburg
country: Germany
facility: DE-Hamburg-ASKLEPIOS
city: Hamburg
country: Germany
facility: DE-Hamburg-UKE
city: Hamm
country: Germany
facility: DE-Hamm-EVKHAMM
city: Hanau
country: Germany
facility: DE-Hanau-KLINIKUMHANAU
city: Hannover
country: Germany
facility: DE-Hannover-MHHANNOVER
city: Hannover
country: Germany
facility: DE-Hannover-SILOAHKRH
city: Herne
country: Germany
facility: DE-Herne-MARIENHOSPITALHERNE
city: Homburg
country: Germany
facility: DE-Homburg-UNIKLINIKSAARLAND
city: Karlsruhe
country: Germany
facility: DE-Karlsruhe-KLINIKUMKARLSRUHE
city: Lebach
country: Germany
facility: DE-Lebach-CARITASKHLEBACH
city: Lemgo
country: Germany
facility: DE-Lemgo-KLINIKUMLIPPE
city: Ludwigshafen
country: Germany
facility: DE-Ludwigshafen-KLILU
city: Lüdenscheid
country: Germany
facility: DE-Luedenscheid-KLINIKUMLUEDENSCHEID
city: Magdeburg
country: Germany
facility: DE-Magdeburg-OVGU
city: Mainz
country: Germany
facility: DE-Mainz-KLINKUNIMAINZ
city: Mainz
country: Germany
facility: DE-Mainz-UNIMEDIZINMAINZ
city: Meschede
country: Germany
facility: DE-Meschede-HOCHSAUERLAND
city: Minden
country: Germany
facility: DE-Minden-MUEHLENKREISKLINKEN
city: München
country: Germany
facility: DE-München-IRZTUM
city: München
country: Germany
facility: DE-München-MEDUNIMUNCHIN
city: Offenburg
country: Germany
facility: DE-Offenburg-ORTENAUKLINIKUM
city: Oldenburg
country: Germany
facility: DE-Oldenburg-KLINIKUMOLDENBURG
city: Passau
country: Germany
facility: DE-Passau-KLINIKUMPASSAU
city: Stuttgart
country: Germany
facility: DE-Stuttgart-DIAKSTUTTGART
city: Stuttgart
country: Germany
facility: DE-Stuttgart-KLINIKUMSTUTTGART
city: Traunstein
country: Germany
facility: DE-Traunstein-TSSOB
city: Trier
country: Germany
facility: DE-Trier-MUTTERHAUS
city: Tübingen
country: Germany
facility: DE-Tübingen-MEDUNITUEBINGEN
city: Ulm
country: Germany
facility: DE-Ulm-UNIKLINKULM
city: Villingen-Schwenningen
country: Germany
facility: DE-Villingen-Schwenningen-SBKVS
city: Wuppertal
country: Germany
facility: DE-Wuppertal-HELIOSGESUNDHEIT
city: Cork
country: Ireland
facility: IE-Cork-CUH
city: Dublin
country: Ireland
facility: IE-Dublin 8-STJAMES
city: Dublin
country: Ireland
facility: IE-Dublin 9-BEAUMONT
city: Galway
country: Ireland
facility: IE-Galway-UHGALWAY
city: Vilnius
country: Lithuania
facility: LT-Vilnius-SANTA
city: Luxembourg
country: Luxembourg
facility: LU-Luxembourg-CHL
city: Amersfoort
country: Netherlands
facility: NL-Amersfoort-MEANDERMC
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-AMC
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-OLVG
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-VUMC
city: Arnhem
country: Netherlands
facility: NL-Arnhem-RIJNSTATE
city: Breda
country: Netherlands
facility: NL-Breda-AMPHIA
city: Delft
country: Netherlands
facility: NL-Delft-RDGG
city: Den Bosch
country: Netherlands
facility: NL-Den Bosch-JBZ
city: Den Haag
country: Netherlands
facility: NL-Den Haag-HAGA
city: Dordrecht
country: Netherlands
facility: NL-Dordrecht-ASZ
city: Eindhoven
country: Netherlands
facility: NL-Eindhoven-MAXIMAMC
city: Enschede
country: Netherlands
facility: NL-Enschede-MST
city: Groningen
country: Netherlands
facility: NL-Groningen-UMCG
city: Leeuwarden
country: Netherlands
facility: NL-Leeuwarden-MCL
city: Leiden
country: Netherlands
facility: NL-Leiden-LUMC
city: Maastricht
country: Netherlands
facility: NL-Maastricht-MUMC
city: Nieuwegein
country: Netherlands
facility: NL-Nieuwegein-ANTONIUS
city: Nijmegen
country: Netherlands
facility: NL-Nijmegen-RADBOUDUMC
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-ErasmusMC
city: Utrecht
country: Netherlands
facility: NL-Utrecht-UMCUTRECHT
city: Zwolle
country: Netherlands
facility: NL-Zwolle-ISALA
city: Bergen
country: Norway
facility: NO-Bergen-HELSEBERGEN
city: Oslo
country: Norway
facility: NO-Oslo-OSLOUH
city: Stavanger
country: Norway
facility: NO-Stavanger-HELSESTAVANGER
city: Tromsø
country: Norway
facility: NO-Tromsø-NORTHNOORWEGEN
city: Trondheim
country: Norway
facility: NO-Trondheim-STOLAV
city: Barcelona
country: Spain
facility: ES-Barcelona-CLINICUB
city: Barcelona
country: Spain
facility: ES-Barcelona-GERMANTRIALS
city: Barcelona
country: Spain
facility: ES-Barcelona-ICODURANREYNALS
city: Barcelona
country: Spain
facility: ES-Barcelona-MUTUATERRASSA
city: Barcelona
country: Spain
facility: ES-Barcelona-PARCDESALUTMAR
city: Barcelona
country: Spain
facility: ES-Barcelona-SANTPAU
city: Barcelona
country: Spain
facility: ES-Barcelona-VHEBRON
city: Girona
country: Spain
facility: ES-Girona-ICSTRUETA
city: Madrid
country: Spain
facility: ES-Madrid-CSGREGORIOMARANON
city: Palma
country: Spain
facility: ES-Palma-SSIB
city: Tarragona
country: Spain
facility: ES-Tarragona-JOAN
city: Valencia
country: Spain
facility: ES-Valencia-MALVARROSA
city: Lund
country: Sweden
facility: SE-Lund-SUH
city: Stockholm
country: Sweden
facility: SE-Stockholm-KAROLINSKAHUDDINGE
city: Uppsala
country: Sweden
facility: SE-Uppsala-UPPSALAUH
city: Basel
country: Switzerland
facility: CH-Basel-USB
city: Bellinzona
country: Switzerland
facility: CH-Bellinzona-IOSI
city: Bern
country: Switzerland
facility: CH-Bern-INSEL
city: Fribourg
country: Switzerland
facility: CH-Fribourg-HFR
city: Geneve
country: Switzerland
facility: CH-Geneve (14)-HCUGE
city: Luzern
country: Switzerland
facility: CH-Luzern-LUKS
city: Saint Gallen
country: Switzerland
facility: CH-St. Gallen-KSSG
city: Zürich
country: Switzerland
facility: CH-Zürich-USZ
Study officials:
affiliation: Erasmus MC / HOVON
name: B.J. Wouters
role: PRINCIPAL_INVESTIGATOR
References: