NCT05694312 Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
| NCT ID | NCT05694312 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Condition | Autoimmune Hemolytic Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-11-24 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2023-11-24 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05694312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autoimmune Hemolytic Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05694312 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05694312 currently recruiting?
Yes, NCT05694312 is actively recruiting participants. Contact the research team at p.fazi@gimema.it for enrollment information.
Where is the NCT05694312 trial being conducted?
This trial is being conducted at Florence, Italy, Novara, Italy, Torino, Italy.
Who is sponsoring the NCT05694312 clinical trial?
NCT05694312 is sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. The trial plans to enroll 45 participants.