Many patients with CLL have a weakened immune system due to their disease. It increases their risk of developing serious, treatment-requiring infections such as blood poisoning or pneumonia, which in the worst case may end with fatal outcomes.
Serious infections due to CLL are responsible for one third of all deaths among CLL patients. PreVent-ACaLL study will investigate whether a combination of two known types of cancer drugs can reduce the risk of infection and thus mortality when given preventively to newly diagnosed CLL patients.
A newly developed register-based computer model can predict which patients are at high risk in order to develop infections as a result of their CLL. A preventive treatment might be initiated before patients need chemotherapy. In this way, the cancer disease might be "reset" so that the immune system, which is inhibited by CLL, is restored and the risk of fatal infections is minimized.
CLL diagnosed according to IWCLL criteria within one year prior to randomization
High risk of infection and/or progressive treatment within 2 years according to CLL-TIM
IWCLL treatment indication not fulfilled
Life expectancy > 2 years
Prior CLL treatment (including monoclonal antibodies, chemotherapy, small molecules)
Transformation of CLL (Richter's transformation)
Previous autoimmune disease as AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura) treated with immune suppression or uncontrolled AIHA or ITP
History of PML
Rigshospitalet, Denmark
Lead sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Karolinska Institutet
Collaborator