Using ibrutinib to treat autoimmune hemolytic anemia in patients with chronic lymphocytic leukemia
Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis
This study is testing if the drug ibrutinib can help adults with chronic lymphocytic leukemia who also have autoimmune hemolytic anemia feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Drugs / interventions | rituximab, ibrutinib |
| Locations | 3 sites (Florence and 2 other locations) |
| Trial ID | NCT05694312 on ClinicalTrials.gov |
What this trial studies
This multicenter, phase II study evaluates the efficacy of ibrutinib in treating autoimmune hemolytic anemia (AIHA) in adult patients diagnosed with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or CLL-like monoclonal B-cell lymphocytosis (MBL). Participants will receive ibrutinib at a dosage of 420 mg per day for up to 12 cycles of 28 days, provided there is no progression of CLL or unacceptable toxicity. The study includes a follow-up period of one year after treatment completion to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of CLL/SLL or CLL-like MBL and active AIHA that is either relapsed, steroid-resistant, or steroid-dependent.
Not a fit: Patients with DAT-negative active AIHA or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from AIHA associated with CLL/SLL.
How similar studies have performed: While the use of ibrutinib has been explored in other contexts, this specific application for AIHA in CLL/SLL is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Florence and 2 other locations
- Ematologia Osp Careggi — Florence, Italy (Recruiting)
- Ematologia Osp Maggiore della Carità — Novara, Italy (Recruiting)
- Ematologia Osp Molinette — Torino, Italy (Recruiting)
Study contacts
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.