PONTrack = With ponatinib on the track for treatment-free remission in CML [Germany]

Study title

PONTrack = With ponatinib on the track for treatment-free remission in chronic myeloid leukemia (CML XII)

Scientific title

With ponatinib on the track for treatment-free remission in chronic myeloid leukemia (EudraCT 2018-004564-59)

Indication and most important inclusion criteria

Female or male patients 18 years and older with  CML in chronic phase (CP) with BCR-ABL on the International Scale (IS) between 0.5-0.01%.

Patients can be considered for inclusion in the study if they have not achieved MR4 (defined as < 0,01% BCR-ABL IS) or not achieved a stable MR4 (defined as no continuous MR4 in the last 12 months before inclusion) after at least 3 years of treatment with nilotinib, dasatinib and / or bosutinib in first or second line.

Other criteria may apply.

Short description of intervention

Achieving and maintaining deep molecular response (DMR) to CML treatment is a precondition for successfully discontinuing TKI treatment and achieving treatment-free remission (TFR).

Many patients achieve major molecular response (MMR = BCR-ABL1 transcripts below 0,1% on the International Scale). However, quite a few do not reach DMR or stable DMR (MR4 or better = BCR-ABL below 0.01% IS) even after several years of treatment with TKIs.

The PONTrack study opens the possibility of TFR to these patients as treatment with ponatinib, a highly effective third generation TKI, may help achieve DMR. In Germany, ponatinib is approved for the treatment of CML, but only for patients who no longer benefit from other TKIs (TKI failure) or who do not tolerate other TKIs (intolerance), or for patients with evidence of a T315I mutation.

Following inclusion in this study, patients will be treated with ponatinib for two years. Depending on the molecular response to treatment, the initial dose of 30 mg will be reduced to (down to 15 mg) or increased (up to no more than 45 mg). Using the lowest possible dosage and close monitoring are expected to be associated with a clearly lower risk of adverse effects than seen in other studies while treatment efficacy is expected to be the same.

Discontinuation of TKI treatment after achieving DMR will not be attempted within the PONTrack study, but only after patients have completed their participation in this study. Provided patient informed consent, TKI discontinuation data will be collected in a planned registry to gain scientific knowledge.

Type of study

Therapy optimization trial

Current status

Recruiting

Study sponsor

Heidelberg University
with support from Incyte Biosciences International Sàrl

Scientific lead / contact

Prof. Dr. med. Susanne Saußele
Universitätsmedizin Mannheim
III. Medizinische Klinik, MCC-Studienzentrale
68167 Mannheim

Principal investigator

Prof. Dr. med. Susanne Saußele
Universitätsmedizin Mannheim
III. Medizinische Klinik, MCC-Studienzentrale
68167 Mannheim

Additional information

Links to documents such as patient information, trial website etc...

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

Study information in German on the website of Deutsche CML Allianz

Study centers / principal investigators

Germany

Universitätsklinikum der RWTH Aachen
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Dr. M. Crysandt
52074 Aachen

Klinikum Bayreuth
Medizinische Klinik IV
Prof. Dr. Kiani
95445 Bayreuth

Klinikum Chemnitz
Klinik für Innere Medizin III
PD Dr. M. Hänel
09116 Chemnitz

MVZ Onkologische Kooperation Harz
Dr. Mark-Oliver Zahn
38642 Goslar

Universitätsklinikum Halle
Universitätsklinik und Poliklinik für Innere Medizin IV
PD Dr. Haifa Kathrin Al-Ali
06120 Halle

Onkologisches Ambulanzzentrum Hannover
Prof. Dr. M. Koenigsmann
30171 Hannover

Schwerpunktpraxis Onkologie Heilbronn
PD Dr. Dengler
74072 Heilbronn

Universitätsklinikum Schleswig-Holstein
Campus Lübeck, Klinik für Hämatologie und Onkologie
Dr. F. Wortmann
23568 Lübeck

Universitätsmedizin Mannheim
III. Medizinische Klinik
Prof. S. Saußele
68167 Mannheim

Klinikum Oldenburg AöR
Universitätsklinik für Innere Medizin - Onkologie und Hämatologie
Studienzentrum
Andreas Voß
26133 Oldenburg

Universitätsmedizin Rostock, ZIM II
Klinik für Hämatologie, Onkologie und Palliativmedizin
Prof. C. Junghanß
18057 Rostock

Universitätsklinikum Ulm
Klinik für Innere Medizin III
Priv.-Doz. Dr. med. Frank Stegelmann
Albert-Einstein-Allee 23
89081 Ulm

 

 


 
   
 

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