DECLINE (CAMN107ADE18T) = Imatinib versus nilotinib in CML in chronic phase [Germany]

Study title

DECLINE = Imatinib versus nilotinib in CML in chronic phase

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, NCT02174445, DRKS00006285)

Type of study

Therapy optimization trial

Current status

No longer recruiting

What is the purpose of the study

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.

Key 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.

Key exclusion criteria

Where can I find additional information

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

Study centers / principal investigators


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

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

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

Arnoldstr. 18
01307 Dresden

Praxis Dr. Hauch
Neuwerkstraße 51
99084 Erfurt

Internistische Schwerpunktpraxis Erlangen
Nägelsbachstraße 49c
91052 Erlangen

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

Universitätsklinikum Freiburg
Medizinische Klinik I
Hugstetter Straße 55
79106 Freiburg

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

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

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

Hasselbachplatz 2
39104 Magdeburg

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

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

Überörtliche Gemeinschaftspraxis Pasing und Fürstenfeldbruck
Bäckerstrasse 4
81241 München

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

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

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