RecruitingPhase 2NCT05694312

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

Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis


Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Enrollment

45 participants

Start Date

Nov 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether ibrutinib — a drug used to treat certain blood cancers — can also help patients who develop autoimmune hemolytic anemia (AIHA), a condition where the immune system mistakenly destroys red blood cells, in the context of a slow-growing blood cancer called chronic lymphocytic leukemia (CLL). **You may be eligible if...** - You are over 18 with a diagnosis of CLL, small lymphocytic lymphoma (SLL), or a related pre-cancerous condition called MBL - You have active AIHA with a hemoglobin level of 10 g/dL or lower - Your AIHA did not respond to steroids, requires high-dose steroids long-term, or came back after treatment **You may NOT be eligible if...** - You have severe heart problems (e.g., recent heart attack, uncontrolled arrhythmia) - You have severe liver or kidney problems - You are on blood thinners that cannot be safely managed - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIbrutinib 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.


Locations(3)

Ematologia Osp Careggi

Florence, Italy

Ematologia Osp Maggiore della Carità

Novara, Italy

Ematologia Osp Molinette

Torino, Italy

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NCT05694312


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