Phase 2Completed
Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP)
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)
- Sponsor
- Fundacion CRIS de Investigación para Vencer el Cáncer (Academic or other)
- Enrolment
- 34 enrolled
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Interventions
- Ponatinib 15 MG; Acetylsalicylic acid 100 MG
- Ages
- adults, older adults
- Registry
- NCT04160546, CTIS2023-508993-27-00, EUCTR2018-003281-14
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Proportion of patients with a maintained MMR within 52 weeks following ponatinib Treatment-Free Remission (TFR)
History
Last registry update
Primary completion
Started
Registered