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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2024-02-01

Brief Summary

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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

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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

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CML, Relapsed

Keywords

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CML second stop dasatinib

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Phase 2, multicenter study, prospective, open label, uncontrolled.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dasatinib

2 years of dasatinib treatment before discontinuation if MR 4 is achieved for at least 1 year

Group Type OTHER

Dasatinib

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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J.J.W.M. Janssen

Clinical Hematologist, Deputy Chief of Department of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulla Olsson-Strömberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology, Uppsala University Hospital, Uppsala, Sweden

Umeå, , Sweden

Site Status RECRUITING

Uppsala University Hospital (Akademiska)

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Denmark Finland France Germany Netherlands Norway Sweden

Central Contacts

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Ulla Olsson-Strömberg, MD PhD

Role: CONTACT

Phone: +46 (0) 18-611 00 00

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 38278960 (View on PubMed)

Other Identifiers

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DASTOP2

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

dasatinib

Dasatinib

Interventions

Dasatinib

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

Amsterdam UMC, location VUmc

Responsible Party

J.J.W.M. Janssen

Principal Investigators

Ulla Olsson-Strömberg, MD PhD

Locations

Aarhus University Hospital

Odense University Hospital

Helsinki University Hospital

Centre Hospitalo-Universitaire

University Hospital

VU University medical center

Albert Schweitzer Hospital

Radboud University medical center

Erasmus University medical center

Haukeland, Bergen University Hospital

Oslo University Hospital

Stavanger University Hospital

Tromsø University Hospital

St Olavs Hospital-Trondheim University Hospital

University Hospital

Sunderby Sjukhus

Lund University Hospital

Örebro University Hospital

Karolinska Hospital

Umeå University Hospital

Uppsala University Hospital (Akademiska)

Countries

Central Contacts

Ulla Olsson-Strömberg, MD PhD

Jeroen JW Janssen, MD PhD

Facility Contacts

Jesper Stentoft, MD PhD

Andreja Dimitrijevic, MD PhD

Satu Mustjoki, MD PhD

Perttu Koskenvesa, MD PhD

Lydia Roy, MD PhD

Dominik Wolf, MD PhD

Jeroen JW Janssen, MD PhD

Gert J Ossenkoppele, MD PhD

Peter E Westerweel, MD PhD

Nicole Blijlevens, MD PhD

Peter AW te Boekhorst, MD PhD

Bjørn Tore Gjertsen, MD PhD

Tobias Gedde Dahl, MD PhD

Waleed Majeed, MD PhD

Anders Vik, MD PhD

Henrik Hjorth Hansen, MD PhD

Kourosh Lofti, MD PhD

Arta Dreimane, MDPhD

Anneli Enblom-Larsson, MD PhD

Johan Richter, MD PhD

Mats Björeman, MD PhD

Leif Stenke, MD PhD