drugset / Trial / NCT04160546
Study to Evaluate the Reinduction and Second Stop of TKI with Ponatinib in CML in Molecular Response (ResToP)
Phase 2
Active not recruiting
80 enrolled
CRIS Cancer Foundation
Apices Soluciones S.L. · collabIncyte Biosciences UK · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-01-17
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ponatinib | Small molecule | 15 mg | Oral |
| Background | Aspirin | Small molecule | 100 mg | Oral |