Last updated on June 2018

An Open-label Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response 4 Log (MR4) at Two Years


Brief description of study

This is an open-label, multicenter, randomised phase 3b clinical trial of Imatinib 400 to 800 mg daily versus Nilotinib 300 mg two times daily in chronic phase CML patients with confirmed MMR without MR4.5

Detailed Study Description

This is an open-label, multicenter, randomised phase 3b clinical trial of Imatinib 400 to 800 mg daily versus Nilotinib 300 mg two times daily in chronic phase CML patients with confirmed MMR without MR4.5 (after having received Imatinib 400 to 800 mg daily for at least 18 months) to determine the proportion of patients with confirmed MR4 after two years. Patients in treatment arm A (Imatinib) who do not achieve confirmed MR4 2 years after randomisation will be offered cross-over from Imatinib 400 to 800 mg daily to Nilotinib 300 mg twice daily. One hundred thirty-two (132) patients will be included and randomised 1:1 to each treatment arm.

The study will be stratified by duration of Imatinib treatment before screen-ing (36 months / >36 months) as well as by the level of response at inclusion (MMR / MR4).

Clinical Study Identifier: NCT02174445

Contact Investigators or Research Sites near you

Start Over

Tim Brümmendorf, Prof.

Universit tsklinikum Aachen
Aachen, Germany

Bernhard Heinrich, Dr. med.

Praxis Dr. Bruder / Dr. Heinrich / Prof. Bangerter
Augsburg, Germany

Viktor Janzen, Dr.

Universit tsklinikum Bonn
Bonn, Germany

Thomas Illmer, PD Dr.

Gemeinschaftspraxis
Dresden, Germany

Ulrich Hauch, Dr. med.

Praxis Dr. Hauch
Erfurt, Germany

Michael Eckart, Dr. med.

Internistische Schwerpunktpraxis Erlangen oncosearch
Erlangen, Germany

Ulla von Verschuer, Dr. med.

Praxis f r H matologie/Onkologie Dres. Rudolph, Sengpiel, von Verschuer
Essen, Germany

Nikolas von Bubnoff, Professor

University Medical Center
Freiburg, Germany

Philippe Schafhausen, Dr.

Universit tsklinikum Hamburg-Eppendorf
Hamburg, Germany

Andreas Hochhaus, Prof.

Universit tsklinikum Jena
Jena, Germany

Kathleen Jentsch-Ulrich, PD Dr.

Gemeinschaftspraxis H matologie/Onkologie
Magdeburg, Germany

Martin C. Mueller, Prof.

Klinikum Mannheim GmbH Universit tsklinikum
Mannheim, Germany

Burkhard Schmidt, Dr. med.

ber rtliche Gemeinschaftspraxis H mato-Onkologie Pasing/F rstenfeldbruck
Munich, Germany

Burkhard Otremba, Dr. med.

Onkologische Praxis Oldenburg
Oldenburg, Germany

Georg Jacobs, Dr. med.

Medizinische Statistik Saarbr cken, GbR
Saarbrucken, Germany

Frank Stegelmann, Dr.

Universit tsklinikum Ulm
Ulm, Germany

Christof Scheid, PD Dr.

Universit tsklinik K ln
Köln, Germany

Philipp Jost, PD Dr. med.

Klinikum rechts der Isar, Technische Universit t M nchen
München, Germany