Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
NCT ID: NCT05694312
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2023-11-24
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ibrutinib
Patients will receive ibrutinib 420 mg/day orally for up to 12 cycles of 28 days.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Locations
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Ematologia Osp Careggi
Florence, , Italy
Ematologia Osp Maggiore della Carità
Novara, , Italy
Ematologia Osp Molinette
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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Alessandro Sanna
Role: primary
Riccardo Moia
Role: primary
Marta Coscia
Role: primary
Other Identifiers
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CLL2323
Identifier Type: -
Identifier Source: org_study_id