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Clinical Trials in Italy / NCT05694312
Recruiting Phase 2

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

NCT05694312 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2023-11-24
Last updated
2023-12-01

Condition(s) studied

Autoimmune Hemolytic AnemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMonoclonal B-Cell Lymphocytosis CLL-Type

Investigational drug(s) / intervention(s)

Ibrutinib 420 mg →

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Ematologia Osp Careggi Florence Italy Recruiting
Ematologia Osp Maggiore della Carità Novara Italy Recruiting
Ematologia Osp Molinette Torino Italy Recruiting

More Gruppo Italiano Malattie EMatologiche dell'Adulto trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05694312 on ClinicalTrials.gov ↗ ← All trials in Italy