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

Type of study

7. Treatment discontinuation trials

Phase

2

Current status

Recruiting

Study title

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

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) (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

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

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

December 2024

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