Drug intelligence / Profile preview

fludarabine + cyclophosphamide + rituximab + ibrutinib

Development stage
Phase 2
Lead developer
Institute of Hematology and Blood Diseases Hospital
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

FCR + ibrutinib is an investigational combination chemoimmunotherapy regimen being evaluated for the treatment of chronic lymphocytic leukemia (CLL). The regimen combines the standard FCR backbone—comprising fludarabine (a purine analog), cyclophosphamide (an alkylating agent), and rituximab (an anti-CD20 monoclonal antibody)—with ibrutinib, a small molecule inhibitor of Bruton's tyrosine kinase (BTK). In clinical studies, such as the Phase 2 trial sponsored by the Institute of Hematology & Blood Diseases Hospital in China (NCT03980002), the regimen is sometimes referred to as the 'HAMBURGER regimen' and involves alternating cycles of FCR with ibrutinib monotherapy. The combination aims to achieve deeper remissions and improve minimal residual disease (MRD) negativity rates by combining cytotoxic chemotherapy with targeted inhibition of B-cell receptor signaling.

Other names
FCR-Iibrutinib-FCRFCR plus ibrutinibibrutinib + FCR
02

Targets

CD20 (B-lymphocyte antigen CD20)BTK (Bruton tyrosine kinase)DNADNA polymerase familyEGFR (Epidermal growth factor receptor)ITK (Interleukin 2-inducible T-cell kinase)JAK3 (Janus kinase 3)

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