PONS = Ponatinib in Second Line [Germany]

Type of study

2. Second line trials after therapy failure

Current status

Recruiting

Study title

PONS =Study in Patients With Chronic Leukemia, Where Previous Therapy Failed, and Who Will be Treated With Ponatinib as Second Line Therapy (PONS_11272)

Scientific title

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)

What is the purpose of the study

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.

What will happen during the study

Key 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.

Key exclusion criteria

Where can I find additional information

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

Study sponsor

GWT-TUD GmbH
Incyte Biosciences International Sàrl

Scientific lead / contact

Dr. K. Linke
GWT-TUD GmbH

Principal investigator

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

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
PD Dr. med. Joachim Göthert

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

Halle
Universitätsklinikum Halle
PD Dr. med. Haifa Kathrin Al-Ali

Hamburg
Asklepios Klinik St. Georg
Prof. Dr. med. Ahmet Elmagaacli,

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

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

Minden
UKRUB Universitätsklinik der Ruhr-Universität Bochum
Dr. med. Hans-Joachim Tischler

Ulm
Universitätsklinikum Ulm
PD Dr. med. Frank Stegelmann