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

Официальное название

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

Обзор

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.

Подробное описание

This is a multicenter, phase II study to assess the efficacy of ibrutinib for the treatment of AIHA in adult patients with CLL/SLL or CLL-like MBL.

Patients will receive ibrutinib 420 mg/day PO for up to 12 cycles of 28 days in the absence of CLL progression or unacceptable toxicity. Every patient will be followed-up for 1 year after the completion of study treatment.

Вмешательства

• Препарат Ibrutinib 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.

Первичные конечные точки

• Ibrutinib efficacy in terms of Overall response rate [Срок оценки: at month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 3 центра

• Ematologia Osp Careggi — Florence
• Ematologia Osp Maggiore della Carità — Novara
• Ematologia Osp Molinette — Torino

Идентификаторы

NCT: NCT05694312 · CLL2323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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