Actively Recruiting
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
Led by Gruppo Italiano Malattie EMatologiche dell'Adulto · Updated on 2023-12-01
45
Participants Needed
3
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CLL, small lymphocytic lymphoma (SLL), or CLL-like monoclonal B-cell lymphocytosis (MBL) based on IWCLL guidelines
- Age over 18 years
- Active autoimmune hemolytic anemia (AIHA) that is relapsed after corticosteroid treatment, steroid-resistant, or steroid-dependent requiring more than 10 mg/day of predniso(lo)ne
- AIHA defined by anemia with hemoglobin ≤10 g/dL or requiring transfusions, plus laboratory evidence of hemolysis and positive direct antiglobulin test (DAT)
- For DAT-negative active AIHA, eligibility must be confirmed by the study investigators
- Signed informed consent according to applicable guidelines and laws
You will not qualify if you...
- Contraindications to ibrutinib therapy as determined by the treating physician
- Contraindications listed in the ibrutinib data sheet, including severe liver impairment, allergy to the drug or excipients, or use of warfarin or vitamin K antagonists
- Previous treatment with ibrutinib for CLL
- Current treatment for CLL/SLL or AIHA other than corticosteroids
- Female patients who are pregnant, planning pregnancy, or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Ematologia Osp Careggi
Florence, Italy
Actively Recruiting
2
Ematologia Osp Maggiore della Carità
Novara, Italy
Actively Recruiting
3
Ematologia Osp Molinette
Torino, Italy
Actively Recruiting
Research Team
P
Paola Fazi
CONTACT
E
Enrico Crea
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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