Study to Evaluate the Reinduction and Second Stop of TKI with Ponatinib in CML in Molecular Response (ResToP)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 17, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Chronic Myeloid Leukemia, Chronic Phase
Interventions
DRUG

Ponatinib 15 MG

"Patients will receive ponatinib 15 mg/day for 104 weeks orally. Ponatinib will be self-administered by the patient on a daily schedule.~Acetyl salicylic acid (ASA) (100 mg) will be used such auxiliary medicinal product in order to prevent vascular occlusive events related with ponatinib."

DRUG

Acetylsalicylic acid 100 MG

Patients will receive acetylsalicylic acid 100 mg/day for 104 weeks orally.

Trial Locations (13)

28007

Hospital General Universitario Gregorio Marañón, Madrid

46026

Hospital Universitario y Politécnico La Fe, Valencia

08908

Institut Català D'Oncologia L'Hospitalet (ICO), L'Hospitalet de Llobregat

Unknown

Hospital Ramón y Cajal, Madrid

Hospital Clínico Universitario de Valencia, Valencia

Institut Català d´oncologia Badalona (ICO), Badalona

Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

Complejo Hospitalario Regional de Málaga, Málaga

Hospital Virgen de La Victoria, Málaga

Hospital General Universitario J.M. Morales Meseguer, Murcia

Hospital Universitario de Salamanca, Salamanca

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incyte Biosciences UK

INDUSTRY

collaborator

Apices Soluciones S.L.

INDUSTRY

lead

Fundacion CRIS de Investigación para Vencer el Cáncer

OTHER