Actively Recruiting
Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or CLL-like Monoclonal B-cell Lymphocytosis
Led by Gruppo Italiano Malattie EMatologiche dell'Adulto · Updated on 2023-12-01
45
Participants Needed
3
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
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 dell'Adulto 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.
CONDITIONS
Brief 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 chronic lymphocytic leukemia, small lymphocytic lymphoma, or CLL-like monoclonal B-cell lymphocytosis according to IWCLL guidelines.
- Age 18 years or older.
- Active autoimmune hemolytic anemia that is relapsed after corticosteroid treatment, steroid-resistant, or steroid-dependent.
- Written informed consent provided according to applicable guidelines and laws.
- Eligibility of patients with DAT-negative active AIHA confirmed by the Principal Investigators.
You will not qualify if you...
- Contraindications to ibrutinib therapy as determined by the treating physician or ibrutinib data sheet.
- Previous treatment with ibrutinib for CLL.
- Currently receiving other CLL/SLL or AIHA treatments besides corticosteroids.
- Female patients who are pregnant, planning pregnancy, or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 cycles of 28 days each
Participants receive ibrutinib orally on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Up to 12 monthly visits (in-person)
Duration - 1 year
Participants are followed for 1 year after completing treatment to monitor their health and any long-term effects.
Visits approximately every 3 months during follow-up
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
E
Enrico Crea
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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