Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment (DASTOP2)
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|ClinicalTrials.gov Identifier: NCT03573596|
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|CML, Relapsed||Drug: Dasatinib||Phase 2|
The DASTOP2 study aims to retreat patients who relapse in the Euro-SKI study (or who stopped TKI treatment outside trials but according to EURO-SKI procedures), with TKI for at least another 3 years, out of last two years with dasatinib. 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.
Patients exhibiting hematological relapse after first stop attempt will not be offered a second stop within this study. The same applies to patients in whom TKI was restarted prematurely (without loss of MMR).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase 2, multicenter study, prospective, open label, uncontrolled.|
|Masking:||None (Open Label)|
|Official Title:||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 Multicenter Prospective Trial|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||February 1, 2024|
2 years of dasatinib treatment before discontinuation if MR 4 is achieved for at least 1 year
CML patients who have failed a first stopping attempt and have used any TKI for one year will switch to dasatinib 100 mg qd for an additional 2 years before second stop attempt.
- successful MMR maintenance [ Time Frame: one year ]The proportion of patients maintaining MMR at 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).
- correlates with succesful stop [ Time Frame: 1 year ]Assessment of clinical and biological factors correlating with persistence of MMR or better after second TKI stop.
- reachievement of MR4 [ Time Frame: 1 year ]Number of patients who re-achieved stable MR4, and were offered study participation.
- Time to reachievement of MR4 [ Time Frame: 1 year ]Time to reachievement of MR4 after second loss of MMR.
- Adverse events after TKI withdrawal [ Time Frame: 1 year ]Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs.
- Overall survival [ Time Frame: 1 year ]Overall survival
- Progression-free survival [ Time Frame: 1 year ]Progression-free survival
- TKI restart without prior molecular relapse [ Time Frame: 1 year ]Occurrence of a restart of TKI without prior molecular relapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573596
|Contact: Ulla Olsson-Strömberg, MD PhD||+46 (0) 18-611 00 email@example.com|
|Contact: Jeroen JW Janssen, MD PhDfirstname.lastname@example.org|
|Principal Investigator:||Ulla Olsson-Strömberg, MD PhD||Department of Hematology, Uppsala University Hospital, Uppsala, Sweden|