Phase II Study of Ibrutinib Treatment for Autoimmune Hemolytic Anemia in Adults With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or CLL-like Monoclonal B-Cell Lymphocytosis

What this Trial Is About

Researchers are evaluating ibrutinib therapy for adults with autoimmune hemolytic anemia AIHA who also have chronic lymphocytic leukemia CLL, small lymphocytic lymphoma SLL, or CLL-like monoclonal B-cell lymphocytosis MBL. This phase II, multicenter study aims to assess the effectiveness of ibrutinib in treating AIHA in this patient group. The study is sponsored by the Gruppo Italiano Malattie EMatologiche dellAdulto and focuses on patients with relapsed, steroid-resistant, or steroid-dependent AIHA. Participants will receive ibrutinib at a dose of 420 mg daily by mouth for up to 12 cycles of 28 days each. Treatment will continue unless there is progression of CLL or unacceptable toxicity. After completing the treatment phase, all patients will be monitored for one year to observe their health and response to therapy. During the study, participants will have their response to ibrutinib measured primarily by the overall response rate at 6 months. Researchers will also monitor safety and side effects throughout treatment and the follow-up period. The total involvement includes treatment and one year of follow-up after the final cycle, with regular assessments to track anemia status, hemolysis markers, and general health.

Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL