PONS = Ponatinib in Second Line [Germany]

Study title

PONS Study = Ponatinib for Treatment of Patients with CP-CML after Treatment with Other TKI has Failed

Scientific title

PONS Phase 2 Clinical Trial with Ponatinib 30mg as a Second Line Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to First Line Tyrosine Kinase Inhibitor Treatment
(EudraCT number: 2016-000618-30 / ClinicalTrials.gov no NCT03807479)

Indication and most important inclusion criteria

Adult patients (age ≥ 18) diagnosed with Ph-positive (by cytogenetics) or BCR-ABL-positive (by PCR) chronic myeloid leukemia (CML) in chronic phase.

Patients should have demonstrated to have
- a failure of a prior first line TKI treatment with either imatinib, dasatinib or nilotinib, defined as per European LeukemiaNet (ELN) recommendations,
- or intolerance to prior TKI treatment defined as grade 3 or 4 toxicity, or persistent grade 2 toxicity despite optimal management including dose adjustment, or in a patient where dose reductions are considered to be not in the patient's best interest to obtain an adequate response. Intolerant patients should not have achieved or have lost major cytogenetic molecular response at the time of enrollment.

Patients should also have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, as well as adequate function of liver, kidney and pancreas. Patients should have fully recovered from the acute effects of prior cancer therapy.

Pregnant patients cannot be included.

Additional criteria may apply.

Short description of intervention

This is a non-randomized, open label study evaluating the safety and efficacy of second line ponatinib therapy in patients suffering from Chronic Myeloid Leukemia in Chronic Phase and who are resistant or intolerant to earlier treatment with another Tyrosine Kinase Inhibitor (TKI). Ponatinib will be given at a dose of 30mg. The dose may be reduced further to 15mg. The study is being performed in Germany.

Type of study

2. Second line trials after therapy failure

Current status

Recruiting

Study sponsor

GWT-TUD GmbH
Incyte Biosciences International Sàrl

Scientific lead / contact

J. Bernds
GWT-TUD GmbH

Principal investigator

Prof. Dr. med. Philipp le Coutre
Charité - Universitätsmedizin Berlin
Department of Hematology, Oncology and Tumor Immunology
10117 Berlin, Germany

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Germany

Aachen
Universitätsklinikum RWTH Aachen
Medizinische Klinik IV
Dr. med. Martina Crysandt

Berlin
Charité - Universitätsmedizin Berlin
Campus Virchow Klinikum
Prof. Dr. med. Philipp le Coutre

Essen
Universitätsklinikum Essen gGmbH
Dr. med. Joachim Göthert

Marburg
Universitätsklinikum Gießen und Marburg GmbH
Prof. Dr. med. Andreas Burchert

Greifswald
Universitätsmedizin Greifswald
Prof. Dr. med. Christian Andreas Schmidt

Mannheim
III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
Prof. Dr. med. Susanne Saußele

 


 
   
 

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