Spots Global Cancer Trial Database for Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP)
Official 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)
Study ID: NCT04160546
Conditions
Study Description
Brief Summary: The purpose of the present study is to determine the rate of successful treatment-free remission (TFR) within the first 52 weeks following cessation of ponatinib treatment in patients who achieved MR4. Eligible patients had been previously treated with TKI and when patients achieved an optimal molecular response, TKI treatment was discontinued. After loss of response, patients were treated again with a TKI treatment and have documented MR4 for one year at the time of switch to ponatinib to study entry. MR4 is defined as BCR-ABL transcript level ≤ 0.01% IS or undetectable BCR-ABL levels with sample sensitivity of at least 4 log.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut Català D'Oncologia L'Hospitalet (ICO), L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario y Politécnico La Fe, Valencia, Comunidad Valenciana, Spain
Institut Català d´oncologia Badalona (ICO), Badalona, , Spain
Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas De Gran Canaria, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital General Universitario J.M. Morales Meseguer, Murcia, , Spain
Complejo Hospitalario Regional de Málaga, Málaga, , Spain
Hospital Virgen de La Victoria, Málaga, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Contact Details
Name: Joaquín Martínez López, MD
Affiliation: Hospital Universitario 12 de Octubre
Role: PRINCIPAL_INVESTIGATOR
Name: Valentín García Gutierrez, MD
Affiliation: Hospital Universitario Ramon y Cajal
Role: PRINCIPAL_INVESTIGATOR
Name: Juan Carlos Hernández Boluda, MD
Affiliation: Hospital Clínico de Valencia
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
