DASFREE
Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE
Phase 2N = 84NCT01850004
- Population
- Adults (aged 18 years or older) with chronic-phase CML who had received dasatinib for at least 2 years with sustained MR4.5 (confirmed at enrolment and for at least 1 year before entry)
- Design
- Open-label, single-arm phase 2 trial. Adults who had received dasatinib for at least 2 years, with confirmed MR4.5 at enrolment and for at least 1 year before entry (first-line or later-line dasatinib), stopped treatment and were monitored for at least 5 years; dasatinib was restarted if major molecular response was lost. The primary endpoint was the proportion maintaining MMR at 1 year (the TFR rate, reported in an earlier paper).
- Primary endpoint
- TFR
- Arms
- Dasatinib discontinuation (experimental, n = 84): Dasatinib stopped after sustained deep molecular response; restart on relapse
- People
- Shah NP, senior author Lipton JH
Show the numbers
| Endpoint | Analysis | Dasatinib discontinuation | Control | Effect |
|---|---|---|---|---|
| TFRAll 84 patients who discontinued dasatinibTreatment-free remission rate: proportion of patients maintaining major molecular response after stopping dasatinib (dasatinib restarted on loss of MMR), at 2 and 5 years. The primary endpoint of DASFREE was the 1-year rate, reported in an earlier paper; the 2- and 5-year rates are follow-up analyses. | finalShah 2023 | 46% at 2 y; 44% at 5 y (33–54%) | — | 5-year TFR was 44% (37 of 84 patients; Kaplan-Meier estimate 95% CI 33-54) at a minimum follow-up of 60 months (database lock December 2021); the 2-year rate of 46% is restated from the earlier report. 56% (47 of 84) lost MMR and all restarted dasatinib; no relapses occurred after month 39. All evaluable patients who relapsed and restarted dasatinib (46 patients) regained MMR in a median of 1.9 months. The most common adverse event off treatment was arthralgia (18%, 15 of 84); 15 withdrawal events were reported in 9 patients (11%). |
| Endpoint | Analysis | Dasatinib discontinuation | Control | Effect |
|---|---|---|---|---|
| TFRAll 84 patients who discontinued dasatinibTreatment-free remission rate: proportion of patients maintaining major molecular response after stopping dasatinib (dasatinib restarted on loss of MMR), at 2 and 5 years. The primary endpoint of DASFREE was the 1-year rate, reported in an earlier paper; the 2- and 5-year rates are follow-up analyses. | finalShah 2023 | 46% at 2 y; 44% at 5 y (33–54%) | — | 5-year TFR was 44% (37 of 84 patients; Kaplan-Meier estimate 95% CI 33-54) at a minimum follow-up of 60 months (database lock December 2021); the 2-year rate of 46% is restated from the earlier report. 56% (47 of 84) lost MMR and all restarted dasatinib; no relapses occurred after month 39. All evaluable patients who relapsed and restarted dasatinib (46 patients) regained MMR in a median of 1.9 months. The most common adverse event off treatment was arthralgia (18%, 15 of 84); 15 withdrawal events were reported in 9 patients (11%). |