J2N-MC-JZNZ - A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process
- Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/microliter (μL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy
- Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit
- Have a platelet count less than 30,000/μL on 2 occasions more than 5 days apart in the 15 days before randomization
- Have adequate liver, renal, and hematologic functions as defined by a table
- Are willing to follow contraception requirements.

Criteri di esclusione: 

- Have a history of any thrombotic or embolic event within 12 months before screening
- Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization
- Have significant cardiovascular disease
- Have a diagnosis or history of hematologic malignancy
- Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction (PCR) positive for HBV deoxyribonucleic acid (DNA)
- Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA).

Trattamento sperimentale: 

Pirtobrutinib

Trattamento di controllo: 

Placebo

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-518502-40-00

Data di inserimento: 02.07.2026

Promotore

Eli Lilly & Co.

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -