ENESTop = A clinical research study evaluating the possibility to stop the drug nilotinib in chronic myeloid leukemia (CML) patients who have very small amount of leukemia cells remaining after nilotinib treatment

Study title

ENESTop = A clinical research study evaluating the possibility to stop the drug nilotinib in chronic myeloid leukemia (CML) patients who have very small amount of leukemia cells remaining after nilotinib treatment

Scientific title

A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib (EudraCT 2012-003186-18; ClinicalTrials.gov NCT01698905)

Indication and most important inclusion criteria

Chronic myeloid leukemia (CML) chronic phase patients.
Potential participants should have been diagnosed with CML and should have received first-line treatment with imatinib, then switched to nilotinib for at least 2 years prior to study entry with the combined time on imatinib and nilotinib being at least 3 years. Patients must not have documented MR4.5 at the time of switch to nilotinib, and should have achieved MR4.5 on nilotinib.

Short description of intervention

To stop nilotinib treatment in CML-CP patients (who started treatment with ≥ 4 weeks of XX, then switched to nilotinib for a minimum of 2 years (with minimum combined duration on imatinib and nilotinib ≥ 3 years), and achieved XX on nilotinib) who maintained MR4.5 during the 1 year nilotinib treatment on study.

Type of study

Treatment free remission trial

Current status

Recruitment completed

Study sponsor

Novartis Pharma AG

Scientific lead / contact

Yu Jin
Clinical Trial Head

Rafik Fellague-Chebra
Medical Director

Principal investigator

Tim Hughes

Francois-Xavier Mahon

Dong-Wook Kim

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study description in the US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health

"ENESTop brochure: Answers to frequently asked questions patients may have about the study of and treatment with nilotinib"

"ENESTop brochure "Molecular response: a measure of treatment success in Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML)"

Study centers

Argentina
Buenos Aires
Fundaleu

Buenos Aires
Hospital Jose Maria Ramos Mejia


Australia

Box Hill
Box Hill Hospital

Adelaide
Royal Adelaide Hospital

St. Leonards
Royal North Shore Hospital


Belgium

Antwerp
ZNA Stuivenberg Hematology/Oncology

Gent
Universitair Ziekenhuis Gent

Haine-saint-Paul
Jolimont


Brazil

Campinas
Universidade de Campinas

Belo Horizonte
Hospital das Clínicas de Belo Horizonte – UFMG

Goiania
Hospital Universitário de Gôiania

Curitiba
Hospital Santa Casa de Curitiba PUCPR

Porto Alegre
Hospital de Clínicas de Porto Alegre

Rio de Janeiro
Instituto Estadual de Hematologia Arthur de Siqueira Cavalca

São Paulo
Hospital das clinicas da Faculdade de Medicina da USP

São Paulo
Irmandade de Santa Casa de Misericordia de Sao Paulo

Rio de Janeiro
Instituo Nacional do Cancer

São Paulo
Casa de Saude Santa Marcelina


Canada

Toronto
Princess Margaret Hospital

Hamilton
The Juravinski Cancer Clinic

Montreal
Hopital Maisonneuve-Rosemont

Québec
Hopital de I'Enfant Jesus


France

Bordeaux
Institut Bergonie

Pierre-Benite Cédex
Centre Hospitalier Lyon-Sud

Vandoeuvre les Nancy
CHU Brabois

Grenoble Cedex 9
Hopital Albert Michallon

Strasbourg Cedex
GH St. Vincent-Clinique Ste Anne


Germany

Berlin
Charité Universitätsmedizin Berlin

Ulm
Universitätsklinikum Ulm

Potsdam
MVZ für Blut- und Krebserkrankungen Potsdam

Mannheim
Universitätsmedizin Mannheim

Heilbronn
Onkologie Heilbronn

Leipzig
Universitätsklinikum Leipzig


Greece

Heraklion Crete
University General Hospital of Heraklion

Athens
Attikon Univ. Gen. Hospital of Athens

Athens, Neo Faliro
Metropolitan Hospital

Athens – GR
General Hospital of Athens Evangelismos

Larissa
University General Hospital of Larissa


Israel

Ramat Gan
The Chaim Sheba Medical Center

Petach Tikva
Rabin Medical Center

Haifa
Rambam Medical Center


Japan

Akita
Akita University Hospital

Fukuoka-city
Kyushu University Hospital

Nagoya
Aichi Cancer Center Hospital

Aomori
Aomori Prefecture Central Hospital

Kurume
Kurume University Hospital

Narita
Narita Red Cross Hospital

Chiba-city
Chiba University Hospital

Korea, Republic of
Seoul
Seoul St. Mary's Hospital


Mexico

San Luis Potosí
Centro Regional de Enfermedades Oncologicas

México
Instituto Nacional de Cancerologia

Monterrey
Hospital y Clinica OCA


Netherlands

Amsterdam
VUMC Amsterdam


Poland

Krakow
Collegium Medicum Uniwersytetu Jagielonskiego (Krakow)

Gdansk
Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematolog

Warzawa
Instytut Hematologii i Transfuzjologi (Warszawa)


Russian Federation

Moscow
Hematological Scientific Center of RAMS

St. Petersburg
State Pavlov Medical University

St. Petersburg
Research Institute of Hematology and Blood Transfusion, 16


Singapore

Singapore General Hospital


Spain

Madrid
Hospital Universitario de la Princesa

Sevilla
Hospital Virgen del Rocio

Alicante
Hospital General Universitario de Alicante

Badalona
Hospital Universitario Germans Trias i Pujol

Santander
Hospital Universitario Marques de Valdecilla

Madrid
Hospital Ramon y Cajal

Madrid
Hospital Universitario La Paz

Santa Cruz de Tenerife
Hospital Universitario de Canarias


Tunisia

Tunis
Hôpital Aziza Othmana


United Kingdom

Liverpool
Royal Liverpool University Hospital

Nottingham
Nottingham City Hospital

Bournemouth
Royal Bournemouth Hospital


USA

Los Angeles
USC/Kenneth Norris Comprehensive Cancer Center

Indianapolis
Indiana Blood and Marrow Institute

Duarte
City of Hope National Medical Center

Baltimore
St. Agnes Hospital

Vancouver
Compass Oncology

Galveston
University of TX Medical Branch