Ibrutinib and Standard Immuno-Chemotherapy in Younger, High-Risk Patients With Diffuse Large B-Cell Lymphoma

Sponsor
University Hospital Muenster
Study ID
NCT03399513
Phase
PHASE2
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will investigate if treatment results obtained with R-CHOEP in young high-risk patients with diffuse large B-cell lymphoma can be further improved by the addition of ibrutinib to this regimen.

Key Dates

Start date
May 3, 2018
Status verified
Jan 2024
Primary completion
Dec 23, 2023
Completion
Dec 23, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib and R-CHOEP chemotherapy
    All patients will receive 8 cycles of R-CHOEP immunochemotherapy every two weeks with the following doses per cycle: rituximab 375 mg/m², cyclophosphamide 750 mg/m², doxorubicin 50 mg/m², vincristine 1.4 mg/m² (dose capped at 2 mg), etoposide 300 mg/m², prednisolone 500 mg. In addition, ibrutinib capsules will be administered orally once daily at a dose of 560 mg (4 x 140 mg hard capsules) for 112 days.

Primary Outcome Measure

2-year progression-free survival [ Time Frame: From the day of inclusion into the study until one of the following events occurs, whichever is first: disease progression, relapse, death due to any other cause (assessed up to 4 years). ]

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