This study was conducted to evaluate the complete response rate of Ibrutinib + R-CHOP in patients with Epstein-Barr virus-positive diffuse large B-cell lymphoma.
EBV-positive diffuse large B-cell lymphoma has EBV-mediated carcinogenic signaling pathway activation, and this diverse intracellular pathway may be a potential therapeutic target in this disease. The BTK inhibitor, ibrutinib, targets the B cell receptor signaling pathway and is active against B cell non-Hodgkin lymphoma. As a result, evidence of the antitumor effect of ibrutinib has been accumulated in some B-cell lymphoma forms such as mantle cell lymphoma. The addition of ibrutinib to standard chemotherapy, rituximab-CHOP, is considered to be an effective treatment for patients with EBV-positive diffuse large B-cell lymphomas, because it is known to show a poor response to treatment compared to (NOS) diffuse large B- It can provide benefits to patients. The BTK inhibitor, ibrutinib, targets the B cell receptor signaling pathway and is active against B cell non-Hodgkin lymphoma. As a result, evidence of the antitumor effect of ibrutinib has been accumulated in some B-cell lymphoma forms such as mantle cell lymphoma. The addition of ibrutinib to standard chemotherapy, rituximab-CHOP, is considered to be an effective treatment for patients with EBV-positive diffuse large B-cell lymphomas, because it is known to show a poor response to treatment compared to (NOS) diffuse large B- It can provide benefits to patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
560 mg by mouth daily on day 1-21 per each cycle
375 mg/m2 IV, day 1
750 mg/m2 IV day 1
Samsung Medical Center
Seoul, Seoul, Gangnam-gu, South Korea
complete response rate
To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)
Time frame: From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48 months
Progression-free survival
It is a measure of the period of survival without disease progression
Time frame: the time between the date of treatment start and the date of death due to any cause or date of disease progression..assessed up to 48 months
Overall survival (OS)
It measures the time from start of treatment to death.
Time frame: Time between the start of treatment and the date of death.assessed up to 48 months
Toxicity Profile
Clinical and laboratory toxicity/symptomatology will be graded based on the NCIC CTG v4.03. Adverse events not reported in NCIC CTG will be categorized into mild, moderate, severe, and fatal and further classified to CTCAE Grades 1-4.
Time frame: from the date of informed consent signature to 30 days after last drug administration.
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50 mg/m2 IV day 1
1.4 mg/m2 IV on day 1
100mg per day on day 1-5