Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
Background: Chronic Lymphocytic Leukemia (CLL) is the most common leukemia in the occidental
countries. Until now, it is considered a chronic disease without a cure. The development of
new molecular therapies have showed that the cure may be an option. This protocol propose a
triple sequential therapy with three direct therapies for the leukemic cell: an inhibitor of
Bruton´s tyrosine kinase (ibrutinib), a second generation monoclonal antibody versus CD20
(obinutuzumab) and a BCL-2 inhibitor (venetoclax) as treatment of first or second line in
CLL.
Objective: Negativize the minimal residual disease and by this way obtain longer survivals
(overall survival and relapse free survival).
Design: This is a multicenter, longitudinal, experimental, open, non-randomized and
non-comparable study coordinated by the "Grupo Cooperativo de Hemopatías Malignas" situated
on Hospital Angeles Lomas in Huixquilucan, México. The study, is a phase II clinical study
that will employ three target therapy drugs in sequencing phases. It will start with a BTK
inhibitor as induction, later an anti-CD20 will be used for consolidation and it will end
with a BH3 analog as maintenance for one year. The primary outcome is the negativization of
minimal residual disease.