ResToP = Reinduction and Second Stop of TKI With Ponatinib in CML [Spain]

Study title

ResToP = Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response

Scientific titleStudy to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response

Multicenter, Open-Label, Single Arm, Phase II Exploratory Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP) (ClinicalTrials.gov no. NCT04160546, EudraCT no. 2018-003281-14)

Indication and most important inclusion criteria

This study includes patients who:

- are at least 18 years old
- have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have been diagnosed with BCR-ABL positive and Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CP-CML)
- lost deep molecular response (MR4) after a first attempt of stopping tyrosine kinase inhibitor (TKI) treatment, restarted TKI again and then regained and maintained confirmed MR4 for more than one year
- have adequate end organ function

Other criteria may apply.

Short description of intervention

In this study, patients will be treated with ponatinib 15 mg/day plus acetyl salicylic acid (ASA) 100 mg/day for 104 weeks. After that, ponatinib and ASA will be stopped.

The study will determine the rate of successful treatment-free remission (TFR) within the first 52 weeks after stopping ponatinib treatment in patients who achieved MR4.

Type of study

7. Treatment discontinuation trials

Current status

Recruiting

Study sponsor

Fundacion CRIS de Investigación para Vencer el Cáncer

in collaboration with:

Incyte Biosciences UK
Apices Soluciones S.L.

Scientific lead / contact

Ana Moreno
Apices Soluciones S.L.

Principal investigator

Joaquín Martínez López, MD
Hospital Universitario 12 de Octubre

Valentín García Gutierrez, MD
Hospital Universitario Ramon y Cajal

Juan Carlos Hernández Boluda, MD
Hospital Clínico de Valencia

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 centers / principal investigators

Spain

Badalona
Institut Català d´oncologia Badalona (ICO)

Las Palmas
Hospital Universitario de Gran Canaria Dr. Negrín

Madrid
Hospital Ramón y Cajal

Madrid
Hospital Universitario 12 de Octubre

Madrid
Hospital Universitario La Paz
ontact: Raquel De Paz

Murcia
Hospital General Universitario J.M. Morales Meseguer

Málaga
Complejo Hospitalario Regional de Málaga

Málaga
Hospital Virgen de La Victoria

Salamanca
Hospital Universitario de Salamanca

Valencia
Hospital Clínico Universitario de Valencia


 
   
 

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