Deutsches Leukämie-Studienregister
Studie: DASTOP 2

Kurzübersicht
Öffentlicher Titel Phase II Studie zum 2. Absetzen der TKI-Behandlung bei chronischer myeloischer Leukämie
Wissenschaftl. Titel 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
Kurztitel DASTOP 2
Studiennummer KN/ELN LN_NN_2018_693
Studiengruppe NN
Studienart multizentrisch, einarmig, offen
Studienphase Phase II
Erkrankung Chronische myeloische Leukämie (CML) - Chronische Phase
Leukämiestadium .
Molekularer Marker BCR-ABL
Einschlusskriterien
  • 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
Ausschlusskriterien
  • 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
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 05.06.2018
Kurzprotokoll Kurzprotokoll
Sponsoren Universität Uppsala
Förderer Bristol-Myers Squibb
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT03573596
European Clinical Trials Database - EUDRACT 2016-004106-34
erstellt 18.11.2020 Zenawit Krüger
geändert 23.12.2020 Student Studienregister
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