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


Phase 3
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

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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

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