Trial Information
Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
molecular relapse-free survival
Outcome Description:
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))
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Susanne Saussele, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universitätsmedizin Mannheim, Universität Heidelberg
Authority:
Sweden: Medical Products Agency
Study ID:
ELN-001
NCT ID:
NCT01596114
Start Date:
June 2012
Completion Date:
June 2017
Related Keywords:
- Chronic Myeloid Leukemia
- TKI
- CML
- Stopping
- chronic phase
- in remission
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive