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Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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Myeloid Leukemia

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Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

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Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

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Tyrosine

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

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.

Ulla Olsson-Strömberg, MD PhD

Jeroen JW Janssen, MD PhD

Jesper Stentoft, MD PhD

Andreja Dimitrijevic, MD PhD

Satu Mustjoki, MD PhD

Perttu Koskenvesa, MD PhD

Lydia Roy, MD PhD

Dominik Wolf, 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

Leif Stenke, MD PhD

Lotta Ohm, MD PhD

Berit Markevärn, MD PhD

Stina Söderlund, MD PhD

Mats Björeman, MD PhD

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.

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).

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

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

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

Study results will be published as soon as possible. Steering committee will decide on sharing IPD. This is still pending.

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).

Assessment of clinical and biological factors correlating with persistence of MMR or better after second TKI stop.

Number of patients who re-achieved stable MR4, and were offered study participation.

Time to reachievement of MR4 after second loss of MMR.

Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment	NCT03573596	CML, Relapsed	Dasatinib	18 Years -	Amsterdam UMC, location VUmc
Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment	NCT03573596	CML, Relapsed	Dasatinib	18 Years -	Amsterdam UMC, location VUmc

Spots Global Cancer Trial Database for second stop

Every month we try and update this database with for second stop cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for second stop

Every month we try and update this database with for second stop cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for second stop cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.