ENDURE = Efficacy and Safety of AOP2014 With CML Patients in Remission [France, Germany]

Study title

ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission (ENDURE-CML-IX)

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)

Indication and most important 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.

Short description of intervention

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.

Type of study

Treatment discontinuation trial

Current status

Recruiting

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

Additional information

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

Study centers / principal investigators

France

Lyon
Centre Léon Bérard
Franck-Emmanuel Nicolini, MD
Lyon, 69008

Vandœuvre-lès-Nancy
CHRU Nancy/Brabois
Agnès Guerci-Bresler, MD
Vandœuvre-lès-Nancy, 54500
Agnès Guerci-Bresler, MD

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