A multicenter trial where patients with CML stop medication a second time.

PERSISTENCE OF MAJOR MOLECULAR REMISSION IN CHRONIC MYELOID LEUKEMIA AFTER a second stop of TKI TREATMENT in patients who failed an initial stop attempt: A prospective multicenter study .

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004106-34-FI

Enrollment

134

Registered

2017-01-25

Start date

2017-03-06

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Interventions

Trade Name: SPRYCEL (Dasatinib) Product Name: Sprycel Product Code: L01XE06 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.CML in CP under TKI treatment after failing a prior attempt to stop treatment within EURO-SKI or outside the study but according to EURO-SKI trial procedures. For the latter group this requires at least 3 years of TKI treatment (first line or second line due to intolerance to first line) before first stop, and MR4 for at least one year before stopping, 2.Treated with TKI for at least one year after having failed a prior at-tempt to stop TKI. Previous TKI can be any. 3.Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course. 4.18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33

Exclusion criteria

Exclusion criteria: 1.Previous hematological relapse after first stop of TKI. 2.Previous AP/BC at any time in the history of the disease. 3.Restart of TKI without loss of MMR after first stop 4.Current participation in another clinical study. 5.Previous or planned allogeneic stem cell transplantation. 6.Patients with contra-indications to dasatinib therapy due to comor-bidities. 7.Subjects with acute hepatitis B virus (HBV) infections. 8.Uncontrolled or significant cardiovascular disease. 9. Pulmonary arterial hypertension 9.Pleural or pericardial effusions of any grade at study entry 11. History of significant bleeding disorder unrelated to CML

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective: Assessment of treatment-free remission (persistence of MMR) after sec-ond attempt of TKI discontinuation in patients who failed a relapsed in the EURO-SKI study or under EURO-SKI like conditions Patients must have received least three years of further TKI treatment of which the two last years should be dasatinib. The patients must have been in MR4 for at least one year. ;Secondary Objective: Secondary objectives: 1.Identification of clinical and biological factors correlating with the persistence of MMR or better after stopping TKI a second time. 2.Estimation of overall and progression free survival 3.Evaluation of medico-economic impact of stopping TKI a second time. 4.Time to re-achievement of MR4 after restart of therapy following a second molecular relapse 5.Assessment of incidence of any AEs (e.g. from treatment related musculoskeletal AE ) that arise after stopping TKI treatment a sec-ond time. ;Primary end point(s): The proportion of patients maintaining MMR at 6 and 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1 > 0.1% on IS at one time point).;Timepoint(s) of evaluation of this end point: 6 and 12 months after discontinuing TKI a second time.	—

Measure

Time frame

Main Objective: Main objective: Assessment of treatment-free remission (persistence of MMR) after sec-ond attempt of TKI discontinuation in patients who failed a relapsed in the EURO-SKI study or under EURO-SKI like conditions Patients must have received least three years of further TKI treatment of which the two last years should be dasatinib. The patients must have been in MR4 for at least one year. ;Secondary Objective: Secondary objectives: 1.Identification of clinical and biological factors correlating with the persistence of MMR or better after stopping TKI a second time. 2.Estimation of overall and progression free survival 3.Evaluation of medico-economic impact of stopping TKI a second time. 4.Time to re-achievement of MR4 after restart of therapy following a second molecular relapse 5.Assessment of incidence of any AEs (e.g. from treatment related musculoskeletal AE ) that arise after stopping TKI treatment a sec-ond time. ;Primary end point(s): The proportion of patients maintaining MMR at 6 and 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1 > 0.1% on IS at one time point).;Timepoint(s) of evaluation of this end point: 6 and 12 months after discontinuing TKI a second time.

—

Secondary

Measure	Time frame
Secondary end point(s): Assessment of: 1.Number of patients who re-achieved stable MR4, and were offered study participation; proportion of patients who accept/refuse study participation. 2.Clinical and biological factors correlating with persistence of MMR or better after second TKI stop (BCR-ABL level before 2nd stop, Sokal score, gender, duration and type of TKI-treatment, duration of first TKI-stop, immunological biomarkers) 3.Overall and progression-free survival and the occurrence of a restart of TKI without prior molecular relapse. 4.Net treatment cost savings from the time off TKI therapy a second time considering also the more frequent PCR monitoring. 5.Time to reachievement of MR4 after second loss of MMR. 6.Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AE’s. ;Timepoint(s) of evaluation of this end point: 2 years after stop of TKI therapy	—

Measure

Time frame

Secondary end point(s): Assessment of: 1.Number of patients who re-achieved stable MR4, and were offered study participation; proportion of patients who accept/refuse study participation. 2.Clinical and biological factors correlating with persistence of MMR or better after second TKI stop (BCR-ABL level before 2nd stop, Sokal score, gender, duration and type of TKI-treatment, duration of first TKI-stop, immunological biomarkers) 3.Overall and progression-free survival and the occurrence of a restart of TKI without prior molecular relapse. 4.Net treatment cost savings from the time off TKI therapy a second time considering also the more frequent PCR monitoring. 5.Time to reachievement of MR4 after second loss of MMR. 6.Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AE’s. ;Timepoint(s) of evaluation of this end point: 2 years after stop of TKI therapy

—

Countries

Denmark, Finland, France, Netherlands

Contacts

Public ContactUlla Olsson-Strömberg

Uppsala University Hospital

ulla.stromberg@talk21.com+46186113738

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026