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

Type of study

7. Treatment discontinuation trials



Current status

Recruitment status unknown

Study title

PonaZero = Effect of Consolidation Treatment with Ponatinib on Treatment-free Remission Rate in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) with Deep Molecular Response

Scientific title

Multicenter, open-label, randomized phase III pilot study to evaluate the effect of a one-year consolidation treatment with ponatinib at two-dose ranges on free-remission rate in patients with Philadelphia-positive chronic myeloid leukemia, who had previously achieved a deep molecular response (EudraCT no. 2017-004565-27, ClinicalTrials.gov NCT04043676)

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. Patients who maintain MR4 during the 52-week ponatinib onsolidation phase can attempt stopping ponatinib and will continue in the 104-week TFR phase.

What will happen during the study

Key inclusion criteria

This study includes patients who:
– have BCR-ABL positive chronic myeloid leukemia in chronic phase (CP-CML)
– have been on imatinib treatment for a minimum of 4 years with confirmed stable deep molecular response (MR4) for a minimum of 12 months prior to enrolment
– are at least 18 years old
– have not had a prior accelerated phase/blast crisis (AP/BC) or stem cell transplant (SCT)
– have an Eastern Co-Operative Group (ECOG) status of 0-2

Key exclusion criteria

Estimated primary completion date

April 2022

Where can I find additional information

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

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study sponsor

Parque Científico de Madrid
Calle Faraday, 7, Campus de Cantoblanco, 28049 Madrid

Scientific lead / contact

Gutierrez, Garcia

Principal investigator


Study centers / principal investigators


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