CML, RelapsedPhase 2DASTOP2NCT03573596
Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment
A Phase 2 study testing Dasatinib in people with CML, Relapsed, run by Amsterdam UMC, location VUmc at 21 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CML, Relapsed
- What is being tested?
- Dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 1 Feb 2018to 1 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CML in chronical phase (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.
- Treated with TKI for at least one year after having failed a prior attempt to stop TKI. Previous TKI can be any.
- Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course.
- 18 years or older.
Who cannot join
- Previous hematological relapse after first stop of TKI.
- Previous AP/BC at any time in the history of the disease.
- Restart of TKI without loss of MMR after first stop
- Current participation in another clinical study.
- Previous or planned allogeneic stem cell transplantation.
- Patients with contra-indications to dasatinib therapy due to comorbidities.
Show all 12Show fewer
- Subjects with acute hepatitis B virus (HBV) infections.
- Uncontrolled or significant cardiovascular disease.
- Pulmonary arterial hypertension.
- Pleural or pericardial effusions of any grade at study entry are excluded
- History of significant bleeding disorder unrelated to CML
- Hypersensitivity to dasatinib and excipients of dasatinib tablets.
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
Sweden7 sites, 7 recruiting
- Recruiting
University Hospital
Linköping
Kourosh Lofti, MD PhD, +46 10 103 00 00, Kourosh.Lotfi@regionostergotland.se
Arta Dreimane, MDPhD, Arta.Dreimane@regionostergotland.se
- Recruiting
Sunderby Sjukhus
Luleå
Anneli Enblom-Larsson, MD PhD, +46 920 28 20 00, anneli.enblom-larsson@nll.se
- Recruiting
Lund University Hospital
Lund
Johan Richter, MD PhD, +46 46 17 10 00, johan.richter@med.lu.se
- Recruiting
Örebro University Hospital
Örebro
Mats Björeman, MD PhD, +46 19 602 10 00, mats.bjoreman@regionorebrolan.se
- Recruiting
Karolinska Hospital
Stockholm
Leif Stenke, MD PhD, +46 8 517 700 00, leif.stenke@ki.se
Lotta Ohm, MD PhD, lotta.ohm@swipnet.se
- Recruiting
Umeå University Hospital
Umeå
Berit Markevärn, MD PhD, +46 90 785 00 00, berit.markevarn@vll.se
- Recruiting
Uppsala University Hospital (Akademiska)
Uppsala
Ulla Olsson-Strömberg, MD PhD, +46 (0) 18-611 00 00, ulla.stromberg@talk21.com
Stina Söderlund, MD PhD, stina.soderlund@akademiska.se
Norway5 sites, 5 recruiting
- Recruiting
Haukeland, Bergen University Hospital
Bergen
Bjørn Tore Gjertsen, MD PhD, +47 55 97 50 00, bjorn.gjertsen@uib.no
- Recruiting
Oslo University Hospital
Oslo
Tobias Gedde Dahl, MD PhD, +47 915 02770, tobias.gedde-dahl@rikshospitalet.no
- Recruiting
Stavanger University Hospital
Stavanger
Waleed Majeed, MD PhD, +47 51 51 80 00, waleed.majeed.mohammed@sus.no
- Recruiting
Tromsø University Hospital
Tromsø
Anders Vik, MD PhD, +47 77 62 60 00, anders.vik@uit.no
- Recruiting
St Olavs Hospital-Trondheim University Hospital
Trondheim
Henrik Hjorth Hansen, MD PhD, +47 72 57 30 00, henrik.hjorth-hansen@ntnu.no
Netherlands4 sites, 4 recruiting
- Not yet recruiting
VU University medical center
Amsterdam, 1081HV
Jeroen JW Janssen, MD PhD, +31204442230, jjwm.janssen@vumc.nl
Gert J Ossenkoppele, MD PhD, +31204442230, g.ossenkoppele@vumc.nl
- Not yet recruiting
Albert Schweitzer Hospital
Dordrecht
Peter E Westerweel, MD PhD, +3178654 11 11, p.e.westerweel@asz.nl
- Not yet recruiting
Radboud University medical center
Nijmegen
Nicole Blijlevens, MD PhD, +3124366 82 06, Nicole.Blijlevens@radboudumc.nl
- Not yet recruiting
Erasmus University medical center
Rotterdam
Peter AW te Boekhorst, MD PhD, +3110 703 49 11, p.teboekhorst@erasmusmc.nl
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Jesper Stentoft, MD PhD, +45 78 45 00 00, jespsten@rm.dk
- Recruiting
Odense University Hospital
Odense
Andreja Dimitrijevic, MD PhD, +45 66 11 33 33, Andreja.Dimitrijevic@rsyd.dk
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Satu Mustjoki, MD PhD, +358-9-47171898
Perttu Koskenvesa, MD PhD, perttu.koskenvesa@helsinki.fi
France1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalo-Universitaire
Créteil
Lydia Roy, MD PhD, +33 1 49 81 21 11, lydia.roy@aphp.fr
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Bonn
Dominik Wolf, MD PhD, +49 228 2870, dominik.wolf@ukbonn.de
About this study
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
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.
Read the detailed description
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).
- Conditions
- CML, Relapsed
- Being tested
- Dasatinib
- Keywords
- CML, second stop, dasatinib
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| dasatinib | Other | 2 years of dasatinib treatment before discontinuation if MR 4 is achieved for at least 1 year Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year
Secondary outcomes (7)
correlates with succesful stop
Assessment of clinical and biological factors correlating with persistence of MMR or better after second TKI stop.
Measured: 1 year
reachievement of MR4
Number of patients who re-achieved stable MR4, and were offered study participation.
Measured: 1 year
Time to reachievement of MR4
Time to reachievement of MR4 after second loss of MMR.
Measured: 1 year
Adverse events after TKI withdrawal
Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs.
Measured: 1 year
Overall survival
Overall survival
Measured: 1 year
Progression-free survival
Progression-free survival
Measured: 1 year
TKI restart without prior molecular relapse
Occurrence of a restart of TKI without prior molecular relapse.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Feb 2018
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CML, RelapsedStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 2, multicenter study, prospective, open label, uncontrolled.
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Skane University Hospital, Helsinki University Central Hospital, Odense University Hospital, Henri Mondor University Hospital, St. Olavs Hospital, Helse Stavanger HF, Aarhus University Hospital, University Hospital, Bonn
- Responsible party
- Principal investigator, J.J.W.M. Janssen, Amsterdam UMC, location VUmc
- Investigators
- Ulla Olsson-Strömberg, MD PhD, Principal investigator, Department of Hematology, Uppsala University Hospital, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573596
- Sponsor's protocol ID
- DASTOP2
- Acronym
- DASTOP2
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study results will be published as soon as possible. Steering committee will decide on sharing IPD. This is still pending.
Publications
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.
PubMed 38278960
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03573596
- Acronym / sponsor ID
- DASTOP2 / DASTOP2
- Conditions
- CML, Relapsed
- Keywords
- CML, second stop, dasatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Skane University Hospital, Helsinki University Central Hospital, Odense University Hospital, Henri Mondor University Hospital, St. Olavs Hospital, Helse Stavanger HF, Aarhus University Hospital, University Hospital, Bonn
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 2, multicenter study, prospective, open label, uncontrolled.
| Arm | Type | Receives |
|---|---|---|
| dasatinib | Other | Drug: Dasatinib2 years of dasatinib treatment before discontinuation if MR 4 is achieved for at least 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CML in chronical phase (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.
- Treated with TKI for at least one year after having failed a prior attempt to stop TKI. Previous TKI can be any.
- Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course.
- 18 years or older.
Key exclusion criteria (12 listed)
- Previous hematological relapse after first stop of TKI.
- Previous AP/BC at any time in the history of the disease.
- Restart of TKI without loss of MMR after first stop
- Current participation in another clinical study.
- Previous or planned allogeneic stem cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibCML 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. | Drug | dasatinib |
Primary outcome
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).
7 secondary outcomes
correlates with succesful stop
Time frame: 1 year
reachievement of MR4
Time frame: 1 year
Time to reachievement of MR4
Time frame: 1 year
Adverse events after TKI withdrawal
Time frame: 1 year
Overall survival
Time frame: 1 year
Progression-free survival
Time frame: 1 year
TKI restart without prior molecular relapse
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Derived from this study: PubMed 38278960Flygt 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.
- Individual participant dataSharing planned: Undecided. Study results will be published as soon as possible. Steering committee will decide on sharing IPD. This is still pending.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Olsson-Strömberg, MD PhD principal investigator
Department of Hematology, Uppsala University Hospital, Uppsala, Sweden
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with CML, Relapsed, run by Amsterdam UMC, location VUmc at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Sweden, Norway, Netherlands, Denmark, Finland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulla Olsson-Strömberg, MD PhD (+46 (0) 18-611 00 00, ulla.stromberg@talk21.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful MMR maintenance (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03573596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.