Tests ibrutinib for autoimmune anemia in people with a blood cancer
Tests ibrutinib in adults with autoimmune hemolytic anemia and chronic lymphocytic leukemia.
Plain-language title generated from the registry record
Registry title: Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
Key facts
- 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
- Phase
- Phase 2
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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Trial code
- NCT05694312EU 2023-509793-38-00
- Record updated
- 1 December 2023
- Original description
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.Read full original descriptionShow less
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 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.
Inclusion: 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: 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.