VITAL-CML = Cell Therapy with Vididencel in CML-CP Patients [Norway]

What is the purpose of the study

This is a study to assess if a cell therapy called vididencel can be administered safely in Chronic Myeloid Leukemia (CML) participants with measurable residual disease (MRD) who are unable to stop treatment with tyrosine kinase inhibitors (TKI). The study also evaluates how well the participants tolerate vididencel.

What will happen during the study

Participants previously treated with a TKI for at least 24 months will receive injections of a cell therapy (vididencel) into the skin. The active treatment period will last about 5 months. Thereafter patients will be followed up regularly for 3 years from the study start.

The first 4 treatments will be given as 2 cell therapy injections into the skin once every 2 weeks over a period of 6 weeks. Further treatments will be given as 1 cell therapy injection into the skin 14 and 18 weeks after the start of participation.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged at least 18 years
• have Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) (according to ELN 2025) treated with the same TKI for at least 24 months
• have measurable residual disease at a stable level over the last 6 months (BCR::ABL1 less than 10% and more than 0.01% on the International Scale).
• have an Eastern Co-Operative Oncology Group (ECOG) status of 0 or 1.

Further criteria apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• are scheduled for allogeneic stem cell transplantation, have undergone allogeneic stem cell transplantation less than 5 years ago, or have undergone allogeneic stem cell transplantation more than 5 years ago and had any sign of graft-versus-host disease
• have uncontrolled or serious infections
• are being treated with ongoing systemic immunosuppressive therapy, other than short use of low dose steroids
• currently have or have recently had an active autoimmune disease, except for well controlled diabetes and stable thyroid disease
• have inadequate liver function.

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 of the U. S. National Institutes of Health.
You can also find a study description in the Clinical Trials Information System (CTIS) . This is a database hosted by the European Medicines Agency (EMA).

Study centers / principal investigators

Norway

Haukeland University Hospital
Bergen
Principal Investigator: Bjorn Torre Gjertsen, MD