Using ibrutinib to treat autoimmune hemolytic anemia in patients with chronic lymphocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Nemtabrutinib to Ibrutinib or Acalabrutinib for First Line Treatment of Chronic Lymphocytic Leukemia

  This study is testing if a new drug called nemtabrutinib works as well as or better than two existing treatments for people with chronic lymphocytic leukemia who haven’t had treatment before.

  Recruiting at 181 sites Phase 3 Merck Sharp & Dohme LLC · Mobile, Alabama and 205 other locations · NCT06136559

• Pirtobrutinib versus ibrutinib for people with CLL or SLL.

  This trial will test whether pirtobrutinib works better or is safer than ibrutinib for adults with CLL/SLL, with a separate part that tries pirtobrutinib alone in treatment‑naïve patients who have a 17p deletion.

  Recruiting at 93 sites Phase 3 Eli Lilly and Company · Anaheim, California and 142 other locations · NCT05254743

• Intermittent dosing of ibrutinib for advanced chronic lymphocytic leukemia

  This study is testing if taking the cancer drug ibrutinib in a 'ON-OFF' way can help people with advanced chronic lymphocytic leukemia stay healthy while possibly having fewer side effects and lower costs.

  Recruiting at 6 sites Phase 1/2 Karolinska University Hospital · Trondheim and 8 other locations · NCT04771507

• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

  This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07734038

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Nemtabrutinib and venetoclax in untreated CLL/SLL

  This phase 2 study tests whether combining nemtabrutinib with venetoclax can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07557056

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.