VARIANT = Venetoclax After TKI to Target Persisting Stem Cells in CML [Germany]
Study title
Venetoclax after TKI-Therapy in CML
Scientific title
Venetoclax After TKI to Target Persisting Stem Cells in CML
Type of study
Treatment optimization trial
Phase
Current status
Recruiting
Other trial ID
EudraCT no. 2022-003069-39; ClinicalTrials.gov NCT05701215
What is the purpose of the study
There is currently no treatment available that can improve the rate of sustained deep molecular remission (DMR) after TKI discontinuation in CML. This is a study to assess whether venetoclax is able to increase the rate of sustained DMR and control minimal residual stem cell disease in patients who have successfully stopped TKI treatment after having achieved and maintained DMR with long-term prior TKI therapy.
What will happen during the study
Eligible patients in stable MR4 will stop TKI treatment and then take venetoclax (400 mg) by mouth (orally) once daily for 12 months.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older.
- have been diagnosed with CML in chronic phase (CML-CP).
- have typical b2a2 and/or b3a2 BCR::ABL1 transcripts.
- have stored DNA from initial diagnosis (prior TKI treatment) for BCR::ABL1 breakpoint analysis
- have received at least 3 years of TKI therapy.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- are using CYP3A-Inhibtors.
- have severely impaired heart, liver or kidney function.
- are pregnant or breast-feeding.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
You can also find a study description in the EU Clinical Trials Registry. This is a database hosted by the European Medicines Agency (EMA).
Study sponsor
Prof. Dr. Thomas Ernst, University of Jena, in collaboration with
Ludwig-Maximilians University of Munich, and AbbVie
Scientific lead / contact
Prof. Dr. Thomas Ernst
University of Jena
Principal investigator
Prof. Dr. Thomas Ernst
University of Jena
Study centers / principal investigators
Germany
Universitätsklinikum der RWTH Aachen
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Dr. Martina Crysandt
52074 Aachen
Universitätsklinikum Jena
Prof. Dr. Thomas Ernst
07747 Jena