BridgeMD
New treatment option for Autoimmune Hemolytic Anemia
Official title Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
ClinicalTrials.gov ID: NCT05694312
What this study is testing
What is Ibrutinib 420 mg?
Ibrutinib 420 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for autoimmune hemolytic anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Italy
- Novara, Italy
- Torino, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Italy; Novara, Italy; Torino, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.