Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04160546 | Study to Evaluate the Reinduction and Second Stop of TKI with Ponatinib in CML in Molecular Response (ResToP) | PHASE2 | ACTIVE NOT_RECRUITING | 80 | — | — | Jan 17, 2020 | Dec 1, 2025 | Dec 31, 2024 | 13 | Spain |
This variable is defined as the number of patients who have a maintained MMR and have not restarted TKI therapy in the first 52 weeks after starting ponatinib TFR phase divided by the number of patients who entered ponatinib TFR phase.
| Arm | Type | Description |
|---|---|---|
| Ponatinib plus ASA treatment | EXPERIMENTAL | Patients will be treated with ponatinib 15 mg/day plus 100 mg/day ASA for 104 weeks. After that, ponatinib and ASA will be stopped. |
| Name | Type | Description |
|---|---|---|
| Ponatinib 15 MG | DRUG | 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. |
| Acetylsalicylic acid 100 MG | DRUG | Patients will receive acetylsalicylic acid 100 mg/day for 104 weeks orally. |
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age. 2. ECOG Performance Status of 0, 1, or 2. 3. Patient with diagnosis of BCR-ABL positive and Ph+ CML-Chronic Phase. 4. Patients who failed the first attempt of TKI discontinuation and after TKI reintroduction they achieve again MR4 an...