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Taking people in ItalyPhase 2

Tests ibrutinib for autoimmune anemia in people with a blood cancer

Tests ibrutinib in adults with autoimmune hemolytic anemia and chronic lymphocytic leukemia.

Key facts

Who runs it
Gruppo Italiano Malattie EMatologiche dell'Adulto
Where
Alessandria, Bari, Brescia, Cagliari, Castelfranco Veneto, Catania, Cosenza, Cuneo, Ferrara, Florence, Genoa, Lecce, Milan, Milano, Modena, Novara, Padova, Parma, Pavia, Perugia, Reggio Calabria, Rome, Trieste, Turin, Varese, and Verona, ItalySee the 28 sites
Registry title
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
Status
Recruiting
Phase
Phase 2
People taking part
45 people, planned
Started
24 Nov 2023
Expected to end
Nov 2026
Type of study
Interventional
Treatments tested
  • Ibrutinib 420 mg
Record updated
1 December 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with CLL/SLL or CLL-like MBL who have active autoimmune hemolytic anemia (AIHA) that came back after, or did not respond to, steroid treatment. It tests ibrutinib.

Age
Over 18 years
Sex
All sexes
Disease stage
CLL/SLL or CLL-like MBL with active AIHA (warm AIHA or cold agglutinin disease). The AIHA must be relapsed after steroids, steroid-resistant, or steroid-dependent. It means anemia (hemoglobin ≤10 g/dL, or >10 g/dL with transfusions), signs of red blood cell breakdown (3 of 4 markers) and a positive DAT test.
Earlier treatment
Must have had corticosteroids (with or without rituximab) for AIHA. Cannot have had ibrutinib before as CLL treatment. Cannot take other CLL/SLL or AIHA treatment except corticosteroids.
Biomarker or test result
Positive DAT test (IgG, C3 or both). People with a negative DAT test need extra confirmation from the trial investigators.

Main reasons for not taking part

  • Cannot take ibrutinib for medical reasons, such as severe liver impairment or allergy to the drug
  • Taking warfarin or other vitamin K antagonists
  • Earlier ibrutinib treatment for CLL
  • Pregnant, planning pregnancy or breastfeeding
  • Other CLL/SLL or AIHA treatment besides corticosteroids

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

  • A.O.SS Antonio Biagio e Cesare Arrigo AlessandriaAlessandria, ItalyTaking people
  • Azienda Ospedaliero Universitaria Consorziale Policlinico Di BariBari, ItalyTaking people
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
  • ARNAS G. BrotzuCagliari, ItalyTaking people
  • Istituto Oncologico VenetoCastelfranco Veneto, ItalyTaking people
  • Humanitas CataniaCatania, ItalyTaking people
  • Azienda Ospedaliera di Cosenza - P.O. ANNUNZIATACosenza, ItalyTaking people
  • Azienda Ospedaliera Santa Croce E CarleCuneo, ItalyTaking people
  • University Hospital Of FerraraFerrara, ItalyTaking people
  • Careggi University HospitalFlorence, ItalyTaking people
  • IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
  • Ospedale Vito Fazzi LecceLecce, ItalyTaking people
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • Istituto Europeo di Oncologia - MilanoMilano, ItalyTaking people
  • Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
  • Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
  • Azienda Ospedale Universita PadovaPadova, ItalyTaking people
  • Azienda Ospedaliero Universitaria ParmaParma, ItalyTaking people
  • Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
  • Hospital Santa Maria Della MisericordiaPerugia, ItalyTaking people
  • Grande Ospedale Metropolitano Bianchi Melacrino MorelliReggio Calabria, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyTaking people
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
  • Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, ItalyTaking people
  • Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • IbrutinibTreatment being tested

    Patients will receive ibrutinib 420 mg/day orally for up to 12 cycles of 28 days.

    Treatment: Ibrutinib 420 mg

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis
Plain-language title
Tests ibrutinib for autoimmune anemia in people with a blood cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 December 2023