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

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)

Indication and most important 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

Short description of intervention

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.

Type of study

7. Treatment discontinuation trials

Current status

Recruiting

Study sponsor

FUNDACIÓN TEÓFILO HERNANDO, Edificio Claid
Parque Científico de Madrid
Calle Faraday, 7, Campus de Cantoblanco, 28049 Madrid

Scientific lead / contact

Gutierrez, Garcia

Principal investigator

Multiple

Additional information

Study description in the EU Clinical Trials Register which is 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



 


 
   
 

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