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

RecruitingPhase 2Ages 18 Years - anyAllGruppo Italiano Malattie EMatologiche dell'Adulto
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค10 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.
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What it tests

  • Ibrutinib 420 mg
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Where

3 sites
Ematologia Osp Careggi
Florence, Italy
Ematologia Osp Maggiore della Caritร 
Novara, Italy
Ematologia Osp Molinette
Torino, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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