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
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Phase 2, multicenter study, prospective, open label, uncontrolled. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
dasatinib
2 years of dasatinib treatment before discontinuation if MR 4 is achieved for at least 1 year
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Drug: Dasatinib
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.

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 00 | ulla.stromberg@talk21.com | |
Contact: Jeroen JW Janssen, MD PhD | +31204442230 | jjwm.janssen@vumc.nl |

Principal Investigator: | Ulla Olsson-Strömberg, MD PhD | Department of Hematology, Uppsala University Hospital, Uppsala, Sweden |
Responsible Party: | J.J.W.M. Janssen, Clinical Hematologist, Deputy Chief of Department of Hematology, Amsterdam UMC, location VUmc |
ClinicalTrials.gov Identifier: | NCT03573596 |
Other Study ID Numbers: |
DASTOP2 |
First Posted: | June 29, 2018 Key Record Dates |
Last Update Posted: | June 29, 2018 |
Last Verified: | June 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Study results will be published as soon as possible. Steering committee will decide on sharing IPD. This is still pending. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
CML second stop dasatinib |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Dasatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |