ResToP = Reinduction and Second Stop of TKI With Ponatinib in CML [Spain]
Study title
Scientific title
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)
Type of study
Trials that are no longer recruiting
Phase
Current status
No longer recruiting
Other trial ID
ClinicalTrials.gov no. NCT04160546, EudraCT no. 2018-003281-14
What is the purpose of the study
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. Patients in this study will have lost deep molecular response (MR4) after a first attempt of stopping tyrosine kinase inhibitor (TKI) treatment, then restarted TKI again and regained and maintained confirmed MR4 for more than one year.
What will happen during the study
Key inclusion criteria
This study includes male or female patients who:
- are at least 18 years old
- have been diagnosed with BCR-ABL positive and Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CP-CML)
- have 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 an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have adequate end organ function.
Key exclusion criteria
This study does not include patients who:
- have a known history of CML in advanced phase (AP) or blast crisis (BC)
- have undergone autologous or allogeneic stem cell transplantation
- have a known atypical transcript
- have CML treatment resistant mutations (T315I, E255K/V, Y253H, F359C/V) detected at any time prior to study entry.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
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
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
Study centers / principal investigators
Spain
Badalona
Institut Català d´oncologia Badalona (ICO)
Contact: Blanca Xicoy
Barcelona
Institut Català D’Oncologia L’Hospitalet (ICO)
Principal Investigator: Concepción Boqué Genovard, MD
Las Palmas
Hospital Universitario de Gran Canaria Dr. Negrín
Contact: María Teresa Gómez Casares
Madrid
Hospital General Universitario Gregorio Marañón
Contact: Santiago Osorio Prendes, MD
Hospital Universitario 12 de Octubre
Contact: Rosa Ayala
Hospital Ramón y Cajal
Contact: Valentín García Gutierrez
Hospital Universitario La Paz
ontact: Raquel De Paz
Murcia
Hospital General Universitario J.M. Morales Meseguer
Contact: Francisca Ferrer Martín
Málaga
Complejo Hospitalario Regional de Málaga
Contact: Antonio Jiménez Velasco
Málaga
Hospital Virgen de La Victoria
Contact: Ana Isabel Rosell Mas
Salamanca
Hospital Universitario de Salamanca
Contact: Fermín Sánchez-Guijo Martín
Valencia
Hospital Clínico Universitario de Valencia
Contact: Juan Carlos Hernández Boluda
Hospital Universitario y Politécnico La Fe
Contact: Elvira Mora Casterá, MD