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.
Encouraging results have been achieved in younger high-risk patients with newly diagnosed diffuse large B-cell lymphoma treated with R-CHOEP. However, more than one fourth of patients still relapse or show primary progressive disease. The outcome of such patients is poor, in particular if first-line therapy contained rituximab. In order to avoid such detrimental situations, we seek to further improve progression-free survival and overall survival by combining R-CHOEP with ibrutinib. Ibrutinib is a first-in-class, orally administered, potent, small-molecule inhibitor of Bruton's tyrosine kinase, a mediator of critical B-cell signaling pathways implicated in the pathogenesis of B-cell cancers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Imbruvica 140 mg hard capsules (Active substance: Ibrutinib)
Immunochemotherapy
HELIOS Hospital Berlin-Buch
Berlin, Germany
Hospital Chemnitz
Chemnitz, Germany
University Hospital Cologne
Cologne, Germany
2-year progression-free survival
Length of time that a patient lives without disease progression or relapse.
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).
Overall survival
The percentage of patients in this study who are still alive.
Time frame: From the day of inclusion into the study to death due to any cause (assessed up to 4 years).
Event-free survival
Length of time that a patient remains free of certain events (disease progression, start of additional, unplanned anti-tumor therapy, relapse, death due to any other cause).
Time frame: From the day of inclusion into the study until one of the following events occurs, whichever comes first: disease progression, start of additional, unplanned anti-tumor therapy, relapse, death due to any other cause (assessed up to 4 years).
Rate of complete remission
Rate of complete remission measured as number of complete remissions divided by the number of patients included.
Time frame: From the day of inclusion into the study until date of complete remission (assessed up to 6 months).
Rate of partial remission
Rate of partial remission measured as number of partial remissions divided by the number of patients included.
Time frame: From the day of inclusion into the study until date of partial remission (assessed up to 6 months).
Overall response rate
Overall response rate measured as number of complete and partial remissions divided by the number of patients included.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Hospital Göttingen
Göttingen, Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany
University Hospital Heidelberg
Heidelberg, Germany
Saarland University Hospital
Homburg, Germany
Johannes Wesling Hospital Minden
Minden, Germany
University Hospital Muenster
Münster, Germany
Rostock University Medical Center
Rostock, Germany
...and 2 more locations
Time frame: From the day of inclusion into the study until date of complete or partial remission (assessed up to 6 months).
Progression rate
Progression rate measured as number of progressions divided by the number of patients included.
Time frame: From the day of inclusion into the study until date of progression during therapy or within 2 months after last treatment course (assessed up to 6 months).
Relapse rate
Relapse rate measured as number of relapses divided by the number of patients included.
Time frame: From the day of inclusion into the study until date of relapse during therapy or within 2 months after last treatment course (assessed up to 6 months).
Duration of response
The time between the initial response to therapy and subsequent disease progression or relapse.
Time frame: From documentation of tumor response to disease progression or relapse (assessed up to 6 months).
Adverse events and serious adverse events
Frequency of adverse events and serious adverse events
Time frame: The documentation of adverse events, including serious adverse events, starts with first study treatment after patient inclusion and ends 100 days after the last application of ibrutinib or any component of R-CHOEP (whichever is applied last).
Rate of treatment-related deaths
The number of deaths during therapy or up to 2 months after the end of therapy divided by the number of patients who started study treatment.
Time frame: From the start of therapy up to 2 months after the end of therapy.
Therapy cycles (number)
Number of therapy cycles
Time frame: From the start of therapy until the end of therapy (assessed up to 4 months).
Therapy cycles (duration)
Duration of therapy cycles
Time frame: From the start of therapy until the end of therapy (assessed up to 4 months).
Used drugs
Cumulative doses of R-CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, rituximab) and ibrutinib.
Time frame: From the start of therapy until the end of therapy (assessed up to 4 months).
Outcome according to lymphoma biology
Lymphoma tissue from all patients will be characterized.
Time frame: From the start of study until the end of study (assessed up to 4 years).