Prognosis in high risk Chronic Lymphocytic Leukemia (CLL) is still unsatisfactory.
Despite the availability of novel pharmaceutical agents (alone or in combination), response to therapy and long-lasting remissions are limited and can be improved.
In the CLL2GIVe trial, the German CLL study group has evaluated a new first line therapy regimen for high risk CLL patients with 17p deletion and/or TP53
In this therapy regimen, patients receive the three agents obinutuzumab, venetoclax and ibrutinib in the first six months, followed by the combination of venetoclax and ibrutinib for another six months.
Subsequently, ibrutinib maintenance therapy is given if undetectable minimal residual disease (MRD) and complete remission according to iwCLL criteria has not been achieved by then.
MRD refers to small numbers of leukaemic cells that may remain in the patient during treatment, or after treatment when the patient has no disease symptoms.
It is the major cause of relapse in leukaemia.
The treatment regimen is a response-adapted limited therapy and showed encouraging response rates.
The rate of complete remissions was 58.5%.
In 80.5% of patients, MRD got undetectable in peripheral blood at cycle 15.
The safety profile was acceptable.
In conclusion, the GIVe regimen is a promising first line treatment option for patients with high risk CLL.