Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
NCT05694312 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2023-12-01
Summary
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.
Conditions
- Autoimmune Hemolytic Anemia
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Monoclonal B-Cell Lymphocytosis CLL-Type
Interventions
- DRUG
-
Ibrutinib 420 mg
Patients will receive ibrutinib orally on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of CLL progression or unacceptable toxicity.
Sponsors & Collaborators
-
Gruppo Italiano Malattie EMatologiche dell'Adulto
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-24
- Primary Completion
- 2025-05-31
- Completion
- 2026-11-30
Countries
- Italy
Study Locations
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