DECLINE = Imatinib versus nilotinib in CML in chronic phase

Study title

DECLINE = Imatinib versus nilotinib in CML in chronic phase [Germany]

Scientific title

Imatinib continuation versus Nilotinib 300 mg twice daily in patients with chronic myeloid leukemia (CML) in chronic phase and major molecular re-sponse (MMR) without molecular response ≥ 4.5 log (MR4.5) receiving Imatinib at a dose of 400 to 800 mg daily. An open-label, randomised multicenter phase 3b study to determine the confirmed rate of molecular response ≥ 4 log (MR4) at two years (EudraCT 2013-000077-68, ClinicalTrials.gov NCT02174445, DRKS00006285)

Indication and most important inclusion criteria

Male or female patients (≥18 years) with CML in first chronic phase (defined as blasts <15% in blood or bone marrow and peripheral blood basophils <20% and platelets ≥ 100 G/L) receiving Imatinib at the standard dose of 400 to 800 mg daily for at least 18 months before informed consent.

Major molecular response (MMR) without molecular response ≥ 4.5 log (MR4.5), i.e. BCR-ABL>0.0032% and ≤0.1% IS confirmed by central laboratory at screening will be required for randomization.

Short description of intervention

This study was designed for patients with CML who have achieved major molecular response on treatment with imatinib but do not qualify for investigational treatment discontinuation since they do not reach ongoing CMR.
Goal of the study is to investigate whether in patients with CML in 1st chronic phase and confirmed MMR receiving imatinib (400 mg daily) a switch to nilotinib (300 mg twice daily) results in a higher proportion of patients with confirmed conversion from MMR to MR4 after two years of study treatment when compared with patients who continue receiving Imatinib (400 mg daily). The study duration for each individual may vary between 27 and 72 months.

Type of study

Therapy optimization trial

Current status

Recruiting

Study sponsor

University Medical Center Freiburg
(with financial support from Novartis)

Scientific lead / contact

Prof. Dr. med. Nikolas von Bubnoff

Principal investigator

Prof. Dr. med. Nikolas von Bubnoff
Universitätsklinikum Freiburg

Additional information

...

Study centers / principal investigators

Germany

Aachen
Universitätsklinikum Aachen
Medizinische Klinik IV, Hämatologie
Pauwelstr. 30
52074 Aachen

Augsburg
Praxis Dr. Bruder / Dr. Heinrich / Prof. Bangerter
Halderstraße 29
86150 Augsburg

Bonn
Universitätsklinikum Bonn
Medizinische Klinik III
Abteilung für Hämatologie und Onkologie
Sigmund-Freud-Str. 25
53105 Bonn

Dresden
Gemeinschaftspraxis
Arnoldstr. 18
01307 Dresden

Erfurt
Praxis Dr. Hauch
Neuwerkstraße 51
99084 Erfurt

Erlangen
Internistische Schwerpunktpraxis Erlangen
oncosearch
Nägelsbachstraße 49c
91052 Erlangen

Essen
Praxis für Hämatologie/Onkologie
Dres. Rudolph, Sengpiel, von Verschuer
Henricistraße 40
45136 Essen

Freiburg
Universitätsklinikum Freiburg
Medizinische Klinik I
Hugstetter Straße 55
79106 Freiburg

Hamburg
Universitätsklinikum Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik
Onkologisches Zentrum
Martinistr. 52
20246 Hamburg

Jena
Universitätsklinikum Jena
Klinik für Innere Medizin III
Erlanger Allee 101
07747 Jena

Köln
Universitätsklinik Köln
Klinik I für Innere Medizin
Kerpener Str. 62, Haus 16
50937 Köln

Magdeburg
Gemeinschaftspraxis
Hämatologie/Onkologie
Hasselbachplatz 2
39104 Magdeburg

Mannheim
Klinikum Mannheim GmbH
Universitätsklinikum
III. Medizinische Klinik
Theodor-Kutzer-Ufer 1-3
68167 Mannheim

München
Technische Universität München
Klinikum rechts der Isar,
III. Medizinische Klinik und Poliklinik
Ismaninger Str. 22
81675 München

München-Pasing
Hämato-Onkologische
Überörtliche Gemeinschaftspraxis Pasing und Fürstenfeldbruck
Bäckerstrasse 4
81241 München

Oldenburg
Onkologische Praxis Oldenburg
Dres. Otremba, Reschke, Zirpel, Kühn
Grüne Straße 11
26121 Oldenburg

Saarbrücken
Medizinische Statistik Saarbrücken, GbR
Dr. Jacob, Prof. Daus, PD Dr. Schmits
Europaallee 5 (Alter Lokschuppen)
66113 Saarbrücken

Ulm
Universitätsklinikum Ulm
Zentrum Innere Medizin
Albert-Einstein-Allee 23
89081 Ulm