Italian Group of Adult Hematological Diseases
This is a multicenter, single arm, phase II study aimed at evaluating ibrutinib therapy for the treatment of AIHA in patients with CLL/SLL or CLL-like MBL.
Autoimmune Hemolytic Anemia
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Monoclonal B-Cell Lymphocytosis CLL-Type
Ibrutinib 420 mg
Phase 2
This is a multicenter, phase II study to assess the efficacy of ibrutinib for the treatment of AIHA in adult patients with CLL/SLL or CLL-like MBL. Patients will receive ibrutinib 420 mg/day PO for up to 12 cycles of 28 days in the absence of CLL progression or unacceptable toxicity. Every patient will be followed-up for 1 year after the completion of study treatment.}}
Study Type : | Interventional |
Estimated Enrollment : | 45 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis |
Actual Study Start Date : | November 24, 2023 |
Estimated Primary Completion Date : | May 2025 |
Estimated Study Completion Date : | November 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Ibrutinib Patients will receive ibrutinib 420 mg/day orally for up to 12 cycles of 28 days. |
Drug: Ibrutinib 420 mg |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Hematology Osp Careggi
Firenze, Italy,
Recruiting
Hematology Osp Maggiore della Carità
Novara, Italy,
Recruiting
Hematology Osp Molinette
Torino, Italy,