drugset
drugset / Trial / NCT03573596

Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment

NCT03573596 ↗

Phase 2 Unknown 134 enrolled Amsterdam UMC, location VUmc Aarhus University Hospital · collabHelse Stavanger HF · collabHelsinki University Central Hospital · collabHenri Mondor University Hospital · collabOdense University Hospital · collabSkane University Hospital · collabSt. Olavs Hospital · collabUniversity Hospital, Bonn · collabUppsala University Hospital · collab
NaSingle-groupOpen-labelTreatment

Summary

This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL \>0.1% (IS)), TKI treatment will once again be restarted.

Timeline

Start
2018-02-01
Primary completion
2023-02-01
Completion
2024-02-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject dasatinib anhydrous Small molecule 100 mg —

Indications

chronic myeloid leukemia