ENESTPath = A Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML

Study title

ENESTPath = A Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML [Europe]

Scientific title

A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID (EudraCT 2012-005124-15), ClinicalTrials.govNCT01743989)

Indication and most important inclusion criteria

Chronic myeloid leukemia (CML)
Patients with a confirmed diagnosis of chronic phase Ph+ CML and with previous first-line treatment with imatinib for at least 2 years; patients should have achieved complete cytogenetic response (CCyR), and should have MR <4.0 at study entry.

Short description of intervention

Changing patients with chronic phase CML (MMR / less than MR4.0) from imatinib to nilotinib (randomized over 2 for 3 years) with the aim of stopping nilotinib in patients with a good response (MR4.0 or better).

Type of studyTreatment free remission

Treatment free remission

Current status

Recruitment completed

The first patients entered the treatment free remission phase in June 2015.

Study sponsor

Novartis Pharma AG

Scientific lead / contact

Luca Dezzani
Angela Pellegrino

Principal investigator

Michele Baccarani
University of Bologna, Italy

Additional information

Study centers

Austria
Graz
LKH Graz Med. Universität Klinik

Innsbruck
Universitätsklinik Innsbruck

Linz
Allgem. öffentl. Krankenhaus der Stadt Linz

Linz
Krankenhaus der Barmherzigen Schwestern

Linz
Krankenhaus der Elisabethinen Linz

Rankweil
Landeskrankenhaus Rankweil

Salzburg
LKH Salzburg / Univ.Klinikum der Paracelsus MPU

Wien
Hanusch-Krankenhaus

Wien
Krankenhaus der Stadt Wien-Hietzing


Belgium
Bruxelles
Cliniques Universitaires Saint-Luc

Edegem
U.Z. Antwerpen

Haine-saint-Paul
CH Jolimont-Lobbes

Kortrijk
AZ Groeninge - Campus Maria's voorzienigheid

Liege
Clinique Saint-Joseph

Tournai
CH WAPI - Site Notre Dame


Bulgaria
Pleven
MHAT "Dr. George Stranski"

Plovdiv
Multifunctional Hospital for Active Treatment "St. George"

Sofia
Alexandrovska University Hospital

Sofia
Specialized Hospital for Active Treatment of Haematological

Varna
Multifunctional Hospital for Active Treatment "Sveta Marina"


Czech Republic
Brno – Bohunice
FN Brno - Bohunice


Denmark
Holstebro
Regionshospitalet Vest Holstebro


Finland
HUS Helsinki
Hematologian tutkimusyksikkö

Turku
TYKS


France
Amiens cedex1
CHU d'Amiens - Hôpital Sud

Angers Cedex 1
CHU d'Angers

Argenteuil Cedex
CHU d'Angers

Auch
Centre Hospitalier General D'auch

Avignon cedex 9
Centre Hospitalier d'Avignon

Bayonne cedex
Centre Hospitalier de la Côte Basque

Besancon cedex
CHU Jean Minjoz

Bordeaux
Institut Bergonie

Bordeaux Cedex
Polyclinique Bordeaux Nord

Brest
CHU de Brest - Hôpital Morvan

Brive la Gaillard
Centre Hospitalier de Brive

Caen cedex
Centre Francois Baclesse

Caen cedex
CHU de Caen

Chalon sur Saône
Centre Hospitalier William Morey

Chambéry cedex
Centre Hospitalier de Chambéry

Clermont Ferrand cedex 1
CHU de Clermont-Ferrand - Hôpital d'Estaing

Corbeil Essonnes
Centre Hospitalier Sud Francilien

Créteil
Centre Hospitalier Henri Mondor

Dunkerque
CHU Dunkerque

Grenoble
Hôpital Albert Michallon

La Roche sur Yon cedex 9
CHD Les Oudairies

Le Chesnay
Hôpital A. Mignot

Le Kremlin Bicetre
Hôpital Kremlin Bicetre

Le Mans cedex 09
Centre Hospitalier Le Mans

Libourne
Hopital Robert Boulin

Lille
CHRU Claude Huriez

Lille cedex
Hôpital Saint Vincent

Limoges cedex
Centre Hospitalier de Limoges

Lorient
Centre Hospitalier Bretagne Sud site de Lorient

Lyon Cedex
Centre Léon Bérard

Marseille
AP-HM - Hôpital de la Conception

Marseille Cédex 9
Institut Paoli Calmettes

Metz cedex 03
CHR Metz Thionville

Montpellier cedex 5
CHRU de Montpellier - Hôpital Saint Eloi

Mulhouse cedex
C H de Mulhouse - Hôpital Emile Muller

Nantes
Hopital Hotel Dieu

Nice Cedex
CHU de Nice Hôp. de l'Archet 1

Orleans
CHR Orleans

Paris
Hopital Saint Antoine

Paris Cedex 10
Hôpital Saint Louis

Paris
Hôpital Necker - Enfants Malades

Paris Cedex 13
Groupe Hospitalier Pitie-Salpetriere

Paris Cedex 14
Hôpital Cochin

Perpignan
CH de Perpignan

Pessac
Hôpital du Haut-Lévêque

Pierre-Benite Cédex
Centre Hospitalier Lyon-Sud

Poitiers
CHU Poitiers

Pontoise
Centre Hospitalier Rene Dubos

Pringy cedex
Centre Hospitalier de la Région d'Annecy

Reims
Hôpital Robert Debré

Rennes
CHRU de Rennes

Rouen Cedex 1
Centre Henri Becquerel-CLCC Hte Normandie

Saint Brieuc cedex 1
CH de Saint-Brieuc - Hôpital Yves Le Foll

Saint-Priest-en-Jarez
Institut de Cancérologie Lucien Neuwirth

Strasbourg cedex
HUS - Hôpital Civil

Strasbourg cedex
G H St Vincent-Clinique Ste Anne

Toulouse cedex 9
CHU de Toulouse - Hôpital Purpan

Toulouse cedex 9
Clinique Pasteur

Tours Cedex 9
CHRU de Tours - Hôpital Bretonneau

Valenciennes
Hôpital de Valenciennes

Vandoeuvre Les Nancy
C.H.U. Nancy - Brabois

Vannes
CH Bretagne Atlantique - Hôpital Prosper Chubert

Vichy
Centre hospitalier de Vichy


Germany

Aschaffenburg
Gemeinschaftspraxis

Augsburg
Gemeinschaftspraxis

Aurich
Praxis Reichert

Baden-Baden
Medizinische Klinik
Neben

Bayreuth
Klinikum Bayreuth

Berlin
Charité Berlin Campus Virchow-Klinikum

Berlin
Praxis Josting

Bottrop
Onkologische Schwerpunktpraxis Bottrop

Braunschweig
Städtisches Klinikum Braunschweig

Bremen
Klinikum Bremen Mitte

Chemnitz
Klinikum
Hänel

Donauwörth
Onkologisches Zentrum-MVZ Filiale

Dresden
Praxis Freiberg-Richter

Eisenach
Praxis Blumenstengel

Essen
Univ.-Klinikum Essen

Frankfurt
Onkologische Gem. Praxis

Goch
Wilhelm-Anton-Hospital Goch gGmbH

Goslar
Onkologische Kooperation Harz

Gütersloh
Städtisches Klinikum Gütersloh

Halle
Praxis

Hamm
Evangelisches Krankenhaus
Lange

Hannover
Königsmann

Ingolstadt
Praxis

Karlsruhe
Städtisches Klinikum Karlsruhe

Kassel
Gemeinschaftspraxis

Kiel
Universität Kiel - Molekulargenetische Medizinische Klinik

Köln
Gemeinschaftspraxis

Köln
Klinikum der Universität zu Köln

Landshut
Tagesklinik
Vehling-Kaiser

Leipzig
Universität Leipzig

Lübeck
Lübecker Onkologische Schwerpunktpraxis

Magdeburg
Praxis PD

Mainz
Hanusch-Krankenhaus

Mannheim
Universitätsklinikum Mannheim

Marburg
Universitätsklinikum Gießen und Marburg GmbH

Memmingen
Praxis Jäckle

München
Gemeinschaftspraxis

München-Pasing
Praxis Schmidt

Münster
Universitätsklinikum Münster
Schmidt

Nürnberg
Internistische Praxisklinik

Offenburg
Klinikum Offenburg-Ortenau

Osnabrück
Niels-Sensen Kliniken
Wamhoff

Potsdam
Praxis

Rostock
Gemeinschaftspraxis

Rostock
Universitätsmedizin Rostock

Schorndorf
Onkologie Zentrum Bürkle

Schwäbisch-Hall
Diakonie Krankenhaus Schwäbisch-Hall

Stade
MVZ Klinik

Stuttgart
Springer Schwerpunktspraxis Onkologie am Hauptbahnhof

Westerstede
Med. Studiengesellschaft NORD-WEST GmbH

Würzburg
Universitätsklinikum
Goebeler

Greece
Athens
Athens General Hospital Laiko

Athens
General Hospital of Athens "Evangelismos"

Athens
General Hospital of Athens G. Gennimatas

Ioannina
University General Hospital of Ioannina

Patras
University General Hospital of Patras

Thessaloniki
General Hospital of Thessaloniki Papanikolaou


Hungary
Budapest
Egyesitett Szent Istvan-Szent Laszlo Korhaz-Rendelointezet

Debrecen
DEOEC, III Belgyogyaszati Klinika

Gyor
Petz Aladar Megyei Oktato Korhaz

Szedged
Szegedi Tudomanyegyetem


Ireland
Dublin, 8
St James' Hospital


Italy
Alessandria
Az. Osp. SS. Antonio e Biagio e C. Arrigo

Ancona
AOU Osp. Riuniti Umberto I-GM Lancisi-G.Salesi-Univ.Studi

Avellino
Az. Ospedaliera S.G. Moscati

Bari
Az.Osp.Univ.Consorziale Policlin.di Bari Univ.degli Studi

Bergamo
Azienda Ospedaliera Papa Giovanni XXIII

Bologna
Az.Osp.di Bologna Policl.S.Orsola-Malpighi Univ.degli Studi

Bolzano
Az. San. dell'Alto Adige - Comprensorio Sanitario di Bolzano

Brescia
Az. Osp. Spedali Civili di Brescia Univ.degli Studi

Cagliari
Ospedale Oncologico A. Businco
Presidio Ospedaliero Roberto Binaghi - ASL Cagliari

Catania
Presidio Ospedaliero Ferrarotto-AOU Policlinico-V Emanuele
Presidio Ospedaliero Garibaldi - Nesima

Catanzaro
Azienda Ospedaliera Pugliese-Ciaccio

Cona
Az. Osp-Univ. Ferrara - Arcispedale S.Anna Univ. degli Studi

Cremona
Az. Osp. Istituti Ospitalieri di Cremona P.O. di Cremona

Firenze
Az. Osp.Universit.Careggi-Univ. Studi di Firenze

Foggia
A.O.Ospedali-Un.OO.RR Foggia-Pres.Ospedali Riuniti di Foggia

Genova
IRCCS Az. Osp. Univ. S.Martino-IST Ist. Naz. Ric. Cancro

Lecce
Presidio Ospedaliero Vito Fazzi ASL Lecce

Livorno
Presidio Ospedaliero Livorno - ASL Livorno 6

Messina
Az.Ospe.Universitaria Policlinico G. Martino Univ.di Messina

Milano
Az.Ospedaliera Niguarda Ca' Granda
Fond.IRCCS Ca'Granda Ospedale Maggiore Policlinico Univ.Stud
Ospedale San Raffaele IRCCS S.r.l.

Mirano
Presidio Ospedaliero di Mirano - Azienda ULSS 13

Modena
A.O.Univ.Policl.di Modena Univ.Studi Modena e R.Emilia

Monza
Ospedale San Gerardo

Napoli
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
A.Osped.-Universit. Policlinico Federico II Univ.degli Studi

Novara
Az. Osp. Univ.Maggiore della Carità

Orbassano
Az.Sanit.Osp.Univers.S.Luigi Gonzaga Orbassano

Padova
Azienda Ospedaliera di Padova Università degli Studi

Pagani
Presidio Ospedaliero Andrea Tortora - ASL Salerno

Palermo
Az.Osp.Univ.Policlinico P.Giaccone Università Studi Palermo
A.O. Ospedali Riuniti Villa Sofia-Cervello - P.O. Cervello
Casa di Cura di Alta Spec. La Maddalena - Dip. Onc III livel

Parma
Az. Ospedaliero Universitaria di Parma

Pavia
Fodazione IRCCS Policlinico S.Matteo Univ.degli Studi Pavia

Perugia
Osp S. Maria della Misericordia-A.O. Perugia - Univ. Studi

Pesaro
Azienda Ospedaliera Ospedale San Salvatore

Pescara
Presidio Ospedaliero Spirito Santo-AUSL Pescara

Piacenza
Presidio Ospedaliero di Piacenza AUSL Piacenza

Pisa
A.O.Univ.Pisana-Pres.Osp.S.Chiara-Univ.degli Studi

Potenza
Azienda Ospedaliera S. Carlo

Reggio Calabria
A.O. Bianchi Melacrino Morelli - Presidio Ospedali Riuniti

Reggio Emilia
Az.Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova

Roma
A.O.Policlinico Umberto I - Università La Sapienza
Ospedale S. Eugenio ASL Roma C
Policlinico A. Gemelli-Università Cattolica del Sacro Cuore
Fondaz.Policlin.Tor Vergata-Univ. degli Studi Tor Vergata

Rossano
Presidio Ospedaliero Nicola Giannattasio

Salerno
Az.Osp.Univ.O.O.R.R. S. Giovanni di Dio e Ruggi d'Aragona

San Giovanni Rotondo
IRCCS Casa Sollievo della Sofferenza

Siena
Az.Osp.-Universitaria Senese Università degli Studi di Siena

Taranto
Stab.Osped. S.Giuseppe Moscati- P.O.Centrale SS.Annunziata

Terni
Azienda Ospedaliera S. Maria di Terni - Univ. Studi Perugia

Torino
AO Città della Salute e della Scienza Torino - P.O.Molinette

Treviso
Pres.Ospedaliero S.Maria di Ca' Foncello

Tricase
A.O.Pia Fondaz.di Culto e Religione Card. G. Panico

Udine
Az.Osped.-Universit.Santa Maria della Misericordia di Udine

Venezia
Ospedale dell'Angelo - Az. ULSS n. 12 Veneziana

Verona
.Osp.Univ.Integrata Verona-Osp.Borgo Roma Univ.degli Studi

Vicenza
Presidio Ospedaliero S.Bortolo ULSS 6 Vicenza


Norway
Bergen
Haukeland University Hospital

Oslo
Rikshospitalet


Portugal
Lisboa
Hospital de Santa Maria

Lisboa
Instituto Português de Oncologia de Lisboa

Porto
Instituto Portugues de Oncologia do Porto

Porto
Centro Hospitalar de São João, E.P.E.

Porto
Centro Hospitalar do Porto, EPE - HSA


Slovakia
Bratislava
Fakultna Nemocnica Poliklinikou

Bratislava
Narodny onkologicky ustav - oddelenie klinickej onkologie

Martin
Martinsk.Fakultna Nemocnica


Spain
Alcala de Henares
Hospital Principa de Asturias

Alicante
Hospital General Universitario de Alicante

Alzira
Hospital de la Ribera

Badalona
Hospital Universitario Germans Trias i Pujol

Baracaldo
Hospital de Cruces

Barcelona
Hospital Clinic l Provincial De Barcelona

Barcelona
Hospital de la Santa Creu i Sant Pau

Barcelona
Hospital del Mar

Barcelona
Hospital Vall D'Hebron

Bilbao
Hospital de Basurto

Caceres
San Pedro De Alcantara Hospital

Cordoba
Hospital Reina Sofia

El Palmar
Hospital Universitario Virgen Arrixaca

Gasteiz
Hospital Txagorritxu

Girona
Hospital Universitario de Girona Dr. Josep Trueta

Granada
Hospital Virgen de las Nieves

Hospitalet de LLobregat
Hospital Durans I Reynals-ICO

Jaen
Complejo Hospitalario de Jaen

La Coruna
Complejo Uni. Hosp. A Coruna ( antes Hospital Juan Canalejo)

León
Hospital Virgen Blanca de León

Madrid
Fundacion Jimenez Diaz

Madrid
Hospital Clinico San Carlos

Madrid
Hospital 12 de Octubre

Madrid
Hospital Gregorio Marañon

Madrid
Hospital Infanta Leonor

Madrid
Hospital La Paz

Madrid
Hospital Ramon Y Cajal

Madrid
Hospital Universitario de la Princesa

Majadanonda
Hospital Puerta de Hierro

Málaga
Hospital Carlos Haya

Mallorca
Hospital Son Llatzer

Murcia
Hospital Morales Meseguer

Oviedo
Hospital General de Asturias

Palma de Mallorca
Hospital Son Espases

Pamplona
Complejo Hospitalario de Navarra

Pontevedra
Hospital Provincial de Pontevedra

Sabadell
Corporacio Sanitaria Parc Tauli Sabadell

Salamanca
Hospital Universitario de Salamanca

San Sebastian
Hospital de Donostia

Santa Cruz de Tenerife
Hospital Ntra. Sra. Candelaria

Santander
Hospital Universitario Marques de Valdecilla

Santiago de Compostela
Hospital Clinico Universitario Santiago de Compostela

Sevilla
Hospital Universitario Virgen Marcarena

Sevilla
Hospital Virgen del Rocio

Tarragona
Hospital Universitario Joan XXIII

Valencia
Hospital Universitario i Politecnic La Fe

Valladolid
Hospital Clinico Universitario de Valladolid

Vigo
Hospital Xeral de Vigo

Zaragoza
Hospital Universitario Miguel Servet


Sweden
Göteborg
Sahlgrenska Universitetssjukhuset

Lund
Skånes Universitetssjukhus

Stockholm
Karolinska Universitetssjukhuset Solna

 

UK
London
Hammersmith Hospital London
Barts and the London NHS Trust

Edinburgh
Western General Hospital

Manchester
University Hospital of South Manchester
East Yorkshire
Castle Hill Hospital

Oldham
Royal Oldham Hospital

Salford
Salford Royal Hospital