C92.1
Conditions
Interventions
Group 1: Patients >18 years discontinue CML treatment outside of clinical (interventional) trials with the aim of maintaining treatment-free remission, if applicable also subsequently after participa
Sponsors
Universität Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. informed written consent of the patient(s). 2. Only adult patients (= 18 years) 3. confirmed diagnosis of Philadelphia chromosome and / or BCR-ABL1 fusion gene positive chronic myeloid leukaemia (CML) 4. treatment of CML with a tyrosine kinase inhibitor (TKI) in first-line or multi-line, mono- or combined therapy 5. intention to discontinue TKI treatment at the time of entry into the register with the aim of treatment-free remission (for the first time or repeated after previous failed discontinuation attempts). 6. commitment of the participating institution to send all blood samples collected during routine care for the determination of the molecular remission level to the scientific laboratory of the Universitätsmedizin Mannheim for analysis and for the biomaterial database for the duration of the patient's participation in the register. For these samples, the amount of blood to be collected must be increased by 10-30 ml for the scientific analyses.Written informed consent from the patient is required for use in the register.
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collection of full clinical data and biomaterials from patients from the beginning of a discontinuation attempt with the aim of determining genetic and immunological characteristics of patients who are able to maintain deep molecular remission (DMR) in TFR compared to patients who fail to maintain DMR in TFR. The analyses include e.g. sequencing and classification of leukaemia cells as well as of immunological cells such as NK cells from peripheral blood and bone marrow aspirate before discontinuation of the TKI, in TFR, in particular at loss or regaining of the remission levels "MMR" and "MR4" as well as after termination of TFR. The analyses are not funded by this registry and are at the disposal of the German CML Study Group and international registries. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. to assess the criteria followed in TKI discontinuation and TFR monitoring, the course and outcomes of TFR in routine care. 2. to assess the health-related quality of life of patients prior as well as during and post TFR. For this purpose, the standardised and validated patient questionnaires by the EORTC for oncological diseases (EORTC QLQ-C30) and for CML (EORTC QLQ-CML-24) are to be used. 3. estimate the costs of maintaining TKI therapy compared to the costs after TKI discontinuation ( including more frequent PCR monitoring). | — |
Countries
Germany
Contacts
Public ContactGabriele Bartsch
Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim Cancer Center, Studienzentrale
Outcome results
None listed