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

Launched by GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO · Jan 12, 2023

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ClinConnect Summary

This clinical trial is studying the use of a medication called ibrutinib to treat a condition known as autoimmune hemolytic anemia (AIHA) in patients who also have chronic lymphocytic leukemia (CLL) or a related condition. AIHA occurs when the body's immune system mistakenly attacks its own red blood cells, leading to anemia, which means having low levels of hemoglobin (the substance in red blood cells that carries oxygen). The trial is open to adults over the age of 18 who meet specific criteria, including having a diagnosis of CLL or a similar disorder, and experiencing AIHA that has not responded to previous treatments like steroids.

Participants in the trial will receive ibrutinib and will be monitored for how well it works in improving their anemia and overall health. It's important to note that not everyone can participate; for instance, individuals with certain health issues or those who have previously taken ibrutinib for CLL cannot join. The trial is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if they qualify.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of CLL/small lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines.
• • 2. Patients \>18 years old
• • 3. Active AIHA (wAIHA or CAD) that i) is relapsed after previous treatment with corticosteroids (with or without rituximab), or ii) is steroid-resistant (failure to obtain hematologic response within 3 weeks on at least 1 mg/kg predniso(lo)ne), or iii) is steroid-dependent (need to continue on predniso(lo)ne at a dose of \>10 mg/day to maintain a response). AIHA is defined as: anemia (hemoglobin ≤10 g/dL; or hemoglobin \>10 g/dL dependent on transfusions to maintain this level of hemoglobin) and laboratory evidence of hemolysis (presence of 3 of 4 markers: increased reticulocyte count, increased indirect bilirubin, increased lactate dehydrogenase, decreased haptoglobin) and positive DAT (either IgG DAT, C3 DAT or both).
• • 4. Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial.
• • 5. Signed written informed consent according to ICH/EU/GCP and national local laws.
• Exclusion Criteria:
• • 1. Contraindication to ibrutinib therapy as per treating physician's discretion.
• • 2. Contraindication to ibrutinib therapy as per ibrutinib data sheet (severe hepatic impairment, known allergy to the drug or to one of the excipients, concomitant treatment with warfarin or other vitamin K antagonists).
• • 3. Previous exposure to ibrutinib as CLL-directed therapy.
• • 4. Other CLL/SLL- or AIHA-directed treatment at the time of enrollment in the study, other than corticosteroids.
• • 5. Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.