VARIANT = Venetoclax After TKI to Target Persisting Stem Cells in CML [Germany]

Type of study

Treatment optimization trial

Phase

2

Current status

Recruiting

Study title

Venetoclax after TKI-Therapy in CML

Scientific title

Venetoclax After TKI to Target Persisting Stem Cells in CML

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 BCR-ABL1 on the International Scale (IS) of MR4 or better which has been confirmed three times within the past 13 months.
  • 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

December 2025

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