ClinicalTrials.gov record NCT05694312
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a phase II, single-arm study testing oral ibrutinib in adults with CLL/SLL or CLL-like MBL who have active autoimmune hemolytic anemia (AIHA). Participants take ibrutinib 420 mg daily in 28-day cycles for up to 12 cycles and are followed for one year after finishing treatment. The main outcome is hematologic response measured at month 6.
What it is studying. The study is testing whether giving ibrutinib to adults with CLL/SLL or CLL-like MBL and active AIHA produces a hematologic response. Response is measured as the percentage of patients achieving complete or partial response (CR + PR) at month 6.
What the researchers hope to learn. To evaluate the efficacy of ibrutinib for treating AIHA in adults with CLL/SLL or CLL-like MBL, measured by the overall response rate (CR + PR) at month 6.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Ibrutinib 420 mg
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Diagnosis of CLL/small lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines.
- Patients >18 years old
- 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).
- Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial.
- Signed written informed consent according to ICH/EU/GCP and national local laws.
Exclusion criteria
- Contraindication to ibrutinib therapy as per treating physician's discretion.
- 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).
- Previous exposure to ibrutinib as CLL-directed therapy.
- Other CLL/SLL- or AIHA-directed treatment at the time of enrollment in the study, other than corticosteroids.
- Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
This is a multicenter, phase II study to assess the efficacy of ibrutinib for the treatment of AIHA in adult patients with CLL/SLL or CLL-like MBL. 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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will take ibrutinib 420 mg orally once daily in 28‑day cycles for up to 12 cycles, stopping earlier for CLL progression or unacceptable toxicity. They will have regular clinic visits and blood tests to monitor anemia, hemolysis, and side effects, and will be followed for one year after completing study treatment. Screening for eligibility may include review by the study investigators (required for DAT‑negative AIHA cases) and signing informed consent.
How the study is structured. Interventional, open-label, single-group phase II trial. All participants receive ibrutinib 420 mg by mouth daily for repeated 28-day cycles (up to 12 cycles) unless CLL progresses or toxicity prevents continuing. There is no placebo or masking. Participants are followed for one year after stopping study treatment.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Nov 24, 2023
- Primary completion
- May 2025 (estimated)
- Study completion
- November 2026 (estimated)
- Target enrollment
- 45 participants (estimated)
- Last updated on registry
- Dec 1, 2023
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Paola Fazi 📞 0670390528 ✉ p.fazi@gimema.it
- Enrico Crea 📞 0670390514 ✉ e.crea@gimema.it
Participating sites (3)
- Ematologia Osp CareggiRecruiting
Florence · Italy
- Alessandro Sanna
- Ematologia Osp Maggiore della CaritàRecruiting
Novara · Italy
- Riccardo Moia
- Ematologia Osp MolinetteRecruiting
Torino · Italy
- Marta Coscia
Terms used on this page · explanations by MedicalUpdates.ai
- single arm
- All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- corticosteroids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- Principal Investigator
- The doctor or scientist responsible for running the study at a site or overall.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- concomitant treatment
- Other medicines a participant takes during the study. Some must be reported; some are restricted.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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