Ibrutinib, Bortezomib and Rituximab-CHOP for the Treatment of Elderly Patients With CD20+ DLBCL, IPI ≥ 2

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

March 17, 2017

Primary Completion Date

November 12, 2024

Study Completion Date

November 12, 2024

Conditions
Diffuse Large B Cell Lymphoma
Interventions
DRUG

Ibrutinib and Bortezomib + R-CHOP

A pre-phase therapy with Prednisone 100 mg p.o. is mandatory from d-4 until d0. Patients receive 6 cycles of a combined immunochemotherapy with the anti-CD20 antibody Rituximab (375 mg/m2 d0 or d1) together with 6 cycles of a chemotherapy consisting of Cyclophosphamide (750 mg/m2 d1), Doxorubicin (50 mg/m2 d1), Vincristine 1 mg absolute d1), Prednisone (100 mg absolute p.o. d1-5) and Bortezomib s.c. (1.3 mg/m2 C1 on d3 and 8, other cycles d1 and d8), in 21-day intervals and Ibrutinib 560 mg p.o. for individuals \< 65 years and 420 mg p.o. for individuals ≥ 65 years (from d6 of C1 until d21 of C6), followed by two additional 3-week cycles of Rituximab (375 mg/m2).

Trial Locations (1)

13353

Charité - Universitätsmedizin Berlin, Hematology, Oncology and Tumor Immunology, Campus Virchow Klinikum, Berlin

All Listed Sponsors
collaborator

Charite University, Berlin, Germany

OTHER

collaborator

Janssen-Cilag Ltd.

INDUSTRY

lead

Prof. Dr. Clemens Schmitt

OTHER

NCT03129828 - Ibrutinib, Bortezomib and Rituximab-CHOP for the Treatment of Elderly Patients With CD20+ DLBCL, IPI ≥ 2 | Biotech Hunter | Biotech Hunter