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

Last updated: June 19, 2018
Sponsor: VU University Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03573596
DASTOP2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. CML in chronical phase (CP) under TKI treatment after failing a prior attempt to stoptreatment within EURO-SKI or outside the study but according to EURO-SKI trialprocedures. 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, andMR4 for at least one year before stopping.

  2. Treated with TKI for at least one year after having failed a prior attempt to stopTKI. Previous TKI can be any.

  3. Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosisor later during the disease course.

  4. 18 years or older.

Exclusion

Exclusion Criteria:

  1. Previous hematological relapse after first stop of TKI.

  2. Previous AP/BC at any time in the history of the disease.

  3. Restart of TKI without loss of MMR after first stop

  4. Current participation in another clinical study.

  5. Previous or planned allogeneic stem cell transplantation.

  6. Patients with contra-indications to dasatinib therapy due to comorbidities.

  7. Subjects with acute hepatitis B virus (HBV) infections.

  8. Uncontrolled or significant cardiovascular disease.

  9. Pulmonary arterial hypertension.

  10. Pleural or pericardial effusions of any grade at study entry are excluded

  11. History of significant bleeding disorder unrelated to CML

  12. Hypersensitivity to dasatinib and excipients of dasatinib tablets.

Study Design

Total Participants: 134
Study Start date:
February 01, 2018
Estimated Completion Date:
February 01, 2024

Study 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).

Connect with a study center

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense,
    Denmark

    Active - Recruiting

  • Helsinki University Hospital

    Helsinki,
    Finland

    Active - Recruiting

  • Centre Hospitalo-Universitaire

    Créteil,
    France

    Site Not Available

  • University Hospital

    Bonn,
    Germany

    Active - Recruiting

  • VU University medical center

    Amsterdam, 1081HV
    Netherlands

    Site Not Available

  • Albert Schweitzer Hospital

    Dordrecht,
    Netherlands

    Site Not Available

  • Radboud University medical center

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus University medical center

    Rotterdam,
    Netherlands

    Site Not Available

  • Haukeland, Bergen University Hospital

    Bergen,
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger,
    Norway

    Active - Recruiting

  • Tromsø University Hospital

    Tromsø,
    Norway

    Active - Recruiting

  • St Olavs Hospital-Trondheim University Hospital

    Trondheim,
    Norway

    Active - Recruiting

  • University Hospital

    Linköping,
    Sweden

    Active - Recruiting

  • Sunderby Sjukhus

    Luleå,
    Sweden

    Active - Recruiting

  • Lund University Hospital

    Lund,
    Sweden

    Active - Recruiting

  • Karolinska Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • Umeå University Hospital

    Umeå,
    Sweden

    Active - Recruiting

  • Uppsala University Hospital (Akademiska)

    Uppsala,
    Sweden

    Active - Recruiting

  • Örebro University Hospital

    Örebro,
    Sweden

    Active - Recruiting

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