Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP)
Status:
Recruiting
Trial end date:
2024-12-02
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Fundacion CRIS de Investigación para Vencer el Cáncer