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| Name | Class |
|---|---|
| Uppsala University Hospital | OTHER |
| Skane University Hospital | OTHER |
| Helsinki University Central Hospital | OTHER |
| Odense University Hospital |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dasatinib | Other | 2 years of dasatinib treatment before discontinuation if MR 4 is achieved for at least 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| successful MMR maintenance | 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). | one year |
| Measure | Description | Time Frame |
|---|---|---|
| correlates with succesful stop | Assessment of clinical and biological factors correlating with persistence of MMR or better after second TKI stop. | 1 year |
| reachievement of MR4 | Number of patients who re-achieved stable MR4, and were offered study participation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ulla Olsson-Strömberg, MD PhD | Contact | +46 (0) 18-611 00 00 | ulla.stromberg@talk21.com | |
| Jeroen JW Janssen, MD PhD | Contact | +31204442230 | jjwm.janssen@vumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Ulla Olsson-Strömberg, MD PhD | Department of Hematology, Uppsala University Hospital, Uppsala, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38278960 | Derived | Flygt H, Soderlund S, Richter J, Saussele S, Koskenvesa P, Stenke L, Mustjoki S, Dimitrijevic A, Stentoft J, Majeed W, Roy L, Wolf D, Dreimane A, Gjertsen BT, Gedde-Dahl T, Ahlstrand E, Markevarn B, Hjorth-Hansen H, Janssen J, Olsson-Stromberg U. Treatment-free remission after a second TKI discontinuation attempt in patients with Chronic Myeloid Leukemia re-treated with dasatinib - interim results from the DAstop2 trial. Leukemia. 2024 Apr;38(4):781-787. doi: 10.1038/s41375-024-02145-6. Epub 2024 Jan 26. |
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Study results will be published as soon as possible. Steering committee will decide on sharing IPD. This is still pending.
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| OTHER |
| Henri Mondor University Hospital | OTHER |
| St. Olavs Hospital | OTHER |
| Helse Stavanger HF | OTHER_GOV |
| Aarhus University Hospital | OTHER |
| University Hospital, Bonn | OTHER |
Phase 2, multicenter study, prospective, open label, uncontrolled.
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| 1 year |
| Time to reachievement of MR4 | Time to reachievement of MR4 after second loss of MMR. | 1 year |
| Adverse events after TKI withdrawal | Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs. | 1 year |
| Overall survival | Overall survival | 1 year |
| Progression-free survival | Progression-free survival | 1 year |
| TKI restart without prior molecular relapse | Occurrence of a restart of TKI without prior molecular relapse. | 1 year |
| Odense University Hospital | Recruiting | Odense | Denmark |
|
| Helsinki University Hospital | Recruiting | Helsinki | Finland |
|
| Centre Hospitalo-Universitaire | Not yet recruiting | Créteil | France |
|
| University Hospital | Recruiting | Bonn | Germany |
|
| VU University medical center | Not yet recruiting | Amsterdam | 1081HV | Netherlands |
|
| Albert Schweitzer Hospital | Not yet recruiting | Dordrecht | Netherlands |
|
| Radboud University medical center | Not yet recruiting | Nijmegen | Netherlands |
|
| Erasmus University medical center | Not yet recruiting | Rotterdam | Netherlands |
|
| Haukeland, Bergen University Hospital | Recruiting | Bergen | Norway |
|
| Oslo University Hospital | Recruiting | Oslo | Norway |
|
| Stavanger University Hospital | Recruiting | Stavanger | Norway |
|
| Tromsø University Hospital | Recruiting | Tromsø | Norway |
|
| St Olavs Hospital-Trondheim University Hospital | Recruiting | Trondheim | Norway |
|
| University Hospital | Recruiting | Linköping | Sweden |
|
| Sunderby Sjukhus | Recruiting | Luleå | Sweden |
|
| Lund University Hospital | Recruiting | Lund | Sweden |
|
| Örebro University Hospital | Recruiting | Örebro | Sweden |
|
| Karolinska Hospital | Recruiting | Stockholm | Sweden |
|
| Umeå University Hospital | Recruiting | Umeå | Sweden |
|
| Uppsala University Hospital (Akademiska) | Recruiting | Uppsala | Sweden |
|
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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