ENDURE = Efficacy and Safety of AOP2014 With CML Patients in Remission [France, Germany]
Study title
Scientific title
Efficacy and safety of pegylated-proline-interferon alpha 2B (AOP2014) in maintaining deep molecular remission in patients with chronic myeloid leukemia (CML) who discontinue ABL-kinase inhibitory therapy – a randomized phase II, multicenter trial with post-study follow-up (EudraCT no. 2016-001030-94,ClinicalTrials.gov NCT03117816)
Type of study
Treatment discontinuation trial
Current status
No longer recruiting
What is the purpose of the study
Previous clinical studies have shown that about half of all CML patients who achieved good response on long-term therapy manage to stop TKI treatment permanently. Unfortunately, it is not possible to predict whether discontinuation will be successful or not.
The objective of this study is to find out whether temporary treatment with ropeginterferon (AOP2014) can activate the immune system to prevent loss of major molecular remission in CML patients, who discontinue TKI treatment in deep molecular remission of MR4 or better (MR4.5, or MR5).
In this study, patients will be randomly assigned to one of two treatment groups:
Patients in Group A will receive ropeginterferon in the first month after enrolment together with the TKI. After this first month, the TKI therapy will be stopped and paitens will receive ropeginterferon for the next14 months. Ropeginterferon is injected with a pre-filled auto-injection pen under the skin every 2 weeks. It is very well tolerated.
Similar as in the Group A, patients in Group B will discontinue TKI therapy one month after randomization. From then on patients will receive no further CML treatment.
Patients will be closely monitored and treatment outcomes will be assessed.
Key inclusion criteria
This study includes male or female patients who:
– are at least 18 years old
– have been diagnosed with BCR-ABL-positive, chronic myeloid leukemia in chronic phase
– have been treated with a tyrosine kinase inhibitor (TKI) for at least 3 years
– have had confirmation of deep molecular remission of MR4 or better (MR4.5, MR5) at least three times within the last year before study entry.
Patients who failed to discontinueTKI in a prior discontinuation attempt are eligible for this study. Additional criteria may apply.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Philipps University Marburg Medical Center
in collaboration with
Deutsche Krebshilfe e.V., Bonn (Germany)
AOP Orphan Pharmaceuticals AG
Scientific lead / contact
Prof. Dr. med. Andreas Burchert, Marburg
Principal investigator
Multiple
Study centers / principal investigators
France
Bordeaux
Institut Bergonié
Gabriel Etienne, MD
Bordeaux, 33076
Lyon
Centre Léon Bérard
Franck-Emmanuel Nicolini, MD
Lyon, 69008
Vandœuvre-lès-Nancy
CHRU Nancy/Brabois
Agnès Guerci-Bresler, MD
Vandœuvre-lès-Nancy, 54500
Germany
Aachen
Universitätsklinikum RWTH Aachen
Martina Crysant, MD
527074 Aachen
Aschaffenburg
Martine Klausmann, MD
63739 Aschaffenburg
Berlin
Universitätsmedizin Berlin Charite- Campus Virchow Klinikum
Prof. Philipp Le Coutre
13353 Berlin
Bonn
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III
Dr. Jai-Jün Shiue
53105 Bonn
Bremen
Klinikum Bremen Mitte, Medizinische Klinik I
Dr. Mathhias Bormann
28177 Bremen
Dresden
BAG / Onkologische Gemeinschaftspraxis
PD Dr. Thomas Illmer
01307 Dresden
Düsseldorf
Universitätsklinikum Düsseldorf
Prof. Norbert Gattermann
40225 Düsseldorf
Erlangen
Universitätsklinikum Erlangen
Prof. Stefan Krause
91054 Erlangen
Essen
Universitätsklinikum Essen, Klinik für Hämatologie
Dr. Joachim Goethert
45147 Essen
Frankfurt
Klinikum der Goethe Universität, Medizinische Klinik II
Dr. Fabian Lang
60590 Frankfurt
Hamburg
Universitätsklinikum Hamburg Eppendorf
Dr. Philippe Schafhausen
20246 Hamburg
Hamm
Evangelisches Krankenhaus Hamm gGmbH
Dr. Elisabeth Lange
59063 Hamm
Jena
Universitätsklinikum Jena
Prof. Andreas Hochhaus
07747 Jena
Koblenz
Institut für Versorgungsforschung in der Onkologie GbR
Dr. Christoph Lutz
56068 Koblenz
Leipzig
Universitätsklinikum Leipzig
Dr. Georg-Nikolaus Franke
04103 Leipzig
Mainz
Johannes-Gutenberg-Universität
III. Medizinische Klinik
PD Dr. Thomas Kindler
55131 Mainz
Mannheim
Universitätsmedizin Mannheim
Prof. Susanne Saußele
68169 Mannheim
Marburg
Universitätsklinikum Gießen und Marburg GmbH
Prof. Andreas Burchert
35043 Marburg
München
III. Medizinische Klinik TUM
Klinikum rechts der Isar
PD Dr. Philipp Jost
81675 München
Münster
Universitätsklinikum Münster
Dr. Eva Schmidt
48149 Münster
Tübingen
Med. Univ.-Klinik II
Prof. Robert Möhle
72076 Tübingen
Ulm
Universitätsklinikum Ulm
PD Dr. Frank Stegelmann
89081 Ulm
Würzburg
Zentrum für Innere Medizin
Dr. Maria-Elisabeth Goebler
97080 Würzburg