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

Recruiting now · Phase 2

Conditions studied: Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Monoclonal B-Cell Lymphocytosis CLL-Type

In brief

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.

Key facts

Study ID

NCT05694312

Run by

Gruppo Italiano Malattie EMatologiche dell'Adulto

People needed

45

Starts

2023-11-24

Expected to finish

2026-11-01

Last updated by the study team

2023-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CLL/small lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines.
• Patients >18 years old
• 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).
• Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial.
• Signed written informed consent according to ICH/EU/GCP and national local laws.

You may not qualify if…

• Contraindication to ibrutinib therapy as per treating physician's discretion.
• 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).
• Previous exposure to ibrutinib as CLL-directed therapy.
• Other CLL/SLL- or AIHA-directed treatment at the time of enrollment in the study, other than corticosteroids.
• Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.

Where it is running

• Ematologia Osp Careggi — Florence, Italy (enrolling)
• Ematologia Osp Maggiore della Carità — Novara, Italy (enrolling)
• Ematologia Osp Molinette — Torino, Italy (enrolling)

Full record on ClinicalTrials.gov

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