PonaZero = Effect of Consolidation Treatment with Ponatinib on TFR Rate [Spain]

What is the purpose of the study

This is a pilot study to determine the rate of successful treatment-free remission (TFR) in patients who achieved and maintained molecular response 4 (MR4) on ponatinib following at least 4 years of imatinib therapy.

What will happen during the study

This study consists of two phases: the ponatinib consolidation phase (48 weeks) and the ponatinib TFR phase (96 weeks).

In the ponatinib consolidation phase, patients will be treated with ponatinib (15 mg per day). Patients who maintain MR4 during this consolidation phase can attempt stopping ponatinib and will continue in the ponatinib TFR phase.

Key inclusion criteria

This study includes male or female patients who:

• are aged 18 years or older
• have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
• have been diagnosed with BCR-ABL positive chronic myeloid leukemia in chronic phase (CP-CML)
• have been on imatinib as the only TKI treatment for at least 4 years
• have achieved and maintained MR4 for at least 12 months on imatinib, as determined by polymerase chain reaction (PCR) lab test at screening.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

The study does not include patients who:

• have been in advanced phase or blast phase, or underwent allogeneic stem cell transplant
• have a known atypical transcript
• have CML treatment resistant mutation(s)
• have attempted to permanently discontinue imatinib or ponatinib treatment before.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health

You can also find a study description in the EU Clinical Trials Register. This is a database hosted by the European Medicines Agency (EMA).

Study centers / principal investigators

Spain

Badalona, Barcelona, 08916
Hospital Trials i Pujol
Dr. Blanca Xicoy

Barcelona, 08035
Hospital Vall D’Hebron
Dr. Guillermo Orti

Las Palmas De Gran Canaria, 35010
Hospital Universitario de Gran Canarias Dr. Negrin
Dr. Maria Teresa Gomez

Madrid, 28006
Hospital Unversitario de la Princesa
Juan Luis Steegmann, MD PhD

Madrid, 28034
Hospital Universitario Ramon y Cajal
Valentin Garcia Gutierrez, MD PhD

Madrid, 28041
Hospital Universitario Doce de Octubre
Rosa Ayala, MD PhD

Málaga, 29010
Hospital Regional de Malaga
Dr. Antonio Jimenez

Salamanca, 37007
Hospital Universitario de Salamanca
Fermin Sanchez-Guija, MD PhD

Valencia, 46010
Hospital Clinico Universitario de Valencia
Dr. Juan Carlos Hernandez Boluda