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JOURNAL ONKOLOGIE – STUDIE
DASTOP2

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

Rekrutierend

NCT-Nummer:
NCT03573596

Studienbeginn:
Februar 2018

Letztes Update:
29.06.2018

Wirkstoff:
Dasatinib

Indikation (Clinical Trials):
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Amsterdam UMC, location VUmc

Collaborator:
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,

Studienleiter

Ulla Olsson-Strömberg, MD PhD
Principal Investigator
Department of Hematology, Uppsala University Hospital, Uppsala, Sweden

Kontakt

Ulla Olsson-Strömberg, MD PhD
Kontakt:
Phone: +46 (0) 18-611 00 00
E-Mail: ulla.stromberg@talk21.com» Kontaktdaten anzeigen

Studienlocations
(3 von 21)

Helsinki University Hospital
Helsinki
FinlandRekrutierend» Google-Maps
Ansprechpartner:
Satu Mustjoki, MD PhD
Phone: +358-9-47171898

Perttu Koskenvesa, MD PhD
E-Mail: perttu.koskenvesa@helsinki.fi» Ansprechpartner anzeigen
VU University medical center
1081HV Amsterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Jeroen JW Janssen, MD PhD
Phone: +31204442230
E-Mail: jjwm.janssen@vumc.nl

Gert J Ossenkoppele, MD PhD
Phone: +31204442230
E-Mail: g.ossenkoppele@vumc.nl» Ansprechpartner anzeigen
Radboud University medical center
Nijmegen
NetherlandsNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Nicole Blijlevens, MD PhD
Phone: +3124366 82 06
E-Mail: Nicole.Blijlevens@radboudumc.nl» Ansprechpartner anzeigen
Erasmus University medical center
Rotterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Peter AW te Boekhorst, MD PhD
Phone: +3110 703 49 11
E-Mail: p.teboekhorst@erasmusmc.nl» Ansprechpartner anzeigen
St Olavs Hospital-Trondheim University Hospital
Trondheim
NorwayRekrutierend» Google-Maps
Ansprechpartner:
Henrik Hjorth Hansen, MD PhD
Phone: +47 72 57 30 00
E-Mail: henrik.hjorth-hansen@ntnu.no» Ansprechpartner anzeigen
University Hospital
Linköping
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Kourosh Lofti, MD PhD
Phone: +46 10 103 00 00
E-Mail: Kourosh.Lotfi@regionostergotland.se

Arta Dreimane, MDPhD
E-Mail: Arta.Dreimane@regionostergotland.se» Ansprechpartner anzeigen
Karolinska Hospital
Stockholm
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Leif Stenke, MD PhD
Phone: +46 8 517 700 00
E-Mail: leif.stenke@ki.se

Lotta Ohm, MD PhD
E-Mail: lotta.ohm@swipnet.se» Ansprechpartner anzeigen
Uppsala University Hospital (Akademiska)
Uppsala
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Ulla Olsson-Strömberg, MD PhD
Phone: +46 (0) 18-611 00 00
E-Mail: ulla.stromberg@talk21.com

Stina Söderlund, MD PhD
E-Mail: stina.soderlund@akademiska.se» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. 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.

2. Treated with TKI for at least one year after having failed a prior attempt to stop

TKI. Previous TKI can be any.

3. Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis

or later during the disease course.

4. 18 years or older.

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.

Studien-Rationale

Primary outcome:

1. 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).



Secondary outcome:

1. 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.

2. reachievement of MR4 (Time Frame - 1 year):
Number of patients who re-achieved stable MR4, and were offered study participation.

3. Time to reachievement of MR4 (Time Frame - 1 year):
Time to reachievement of MR4 after second loss of MMR.

4. 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.

5. Overall survival (Time Frame - 1 year):
Overall survival

6. Progression-free survival (Time Frame - 1 year):
Progression-free survival

7. TKI restart without prior molecular relapse (Time Frame - 1 year):
Occurrence of a restart of TKI without prior molecular relapse.

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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