Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005631

Trial Description

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Title

Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI

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Trial Acronym

EURO-SKI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of
molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine
Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular
response (MMR) or better after stopping TKI therapy.

Secondary goals include:

- Identification of clinical and biological factors affecting the persistence of complete
molecular remission after stopping TKI (e.g. level of Complete molecular remission
(CMR), risk score, duration of TKI treatment, type of TKI pretreatment)

- Evaluation of quality of life (QoL) in patients stopping TKI

- Evaluation of medico-economic impact of stopping TKI

- Estimating the number of patients in CMR who are eligible for stopping TKI therapy by
setting up a screening log

- Time to recovery of CMR There will be no randomised comparison. Based on the experience
of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month
molecular-relapse-free survival probability of at least 40%. An interim analysis will
be performed after 200 patients have been observed for at least six months. Formally,
it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival
probability P ≤ 40% against the alternative hypothesis H1: Six-month
molecular-relapse-free survival probability P > 40%. Eligible are adult CML patients in
chronic phase on TKI treatment in CMR for at least one year (> 4 log reduction of
BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR
within a standardized CMR laboratory). Clinical and biological monitoring will be
performed during 3 years: Associated scientific projects are performed. Recruitment
period: 2 years; follow up: 3 years. Planned patient recruitment: n=500

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005631
  •   2014/04/29
  •   2012/05/08
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2011-000440-22 
  •   NCT01596114  (ClinicalTrials.gov)
  •   ELN-001  (European LeukemiaNet)
  •   2011-000440-22 
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Health Condition or Problem studied

  •   Chronic Myeloid Leukemia
  •   C92.1 -  Chronic myeloid leukaemia [CML], BCR/ABL-positive
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Interventions/Observational Groups

  •   Other: Stopping treatment with TKI
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
  •   [---]*
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Primary Outcome

- molecular relapse-free survival; time frame: 3 years; Evaluation of molecular relapse-free survival after stopping TKI (survival without molecular relapse defined by BCR-ABL1 > 0.1% on the IS at one time point (loss of major molecular response, MMR))

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Secondary Outcome

- Overall and progression-free survival; time frame: 3 years; Overall and progression-free survival and the probabilities of a restart of TKI without prior molecular relapse
- Treatment costs; time frame: 3 years; Saved treatment costs / country from the time off TKI therapy considering also the more frequent PCR monitoring
- QoL; time frame: 3 years; Patient reported QoL and symptom burden over time
- Time to recovery; time frame: 3 years; Analysing the time to recovery of CMR4 after loss of MMR

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Countries of Recruitment

  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Norway
  •   Netherlands
  •   Portugal
  •   Sweden
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Locations of Recruitment

  • [---]*
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Recruitment

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  •   2012/06/30
  •   500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- CML in CP under treatment with TKI in first line or in second line because of
toxicity to first line TKI or with TKI in combination

- Duration of TKI treatment before enrolment at least 3 years

- At least complete molecular remission MR4

- Before inclusion confirmation of CMR4 through a EUTOS-CMR laboratory

- Baseline data and documentation on treatment before study entry available

- Both sexes but fertile women only if using effective contraceptive

- Health insurance coverage

- 18 years or older

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Exclusion Criteria

- Under 18 years old

- Hospitalized patients without ability to give informed consent

- Adults under law protection or without ability to consent

- Previous or planned allogeneic stem cell transplantation

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Addresses

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    • European LeukemiaNet
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    • Universitätsmedizin Mannheim, Universität Heidelberg
    • Susanne Saussele, Dr. 
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    •   [---]*
    •   [---]*
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    • Susanne Saussele, Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   111
  •   2014/01/06
* This entry means the parameter is not applicable or has not been set.