NCT02670616

Study of Ibrutinib in Combination With Rituximab-CHOP in Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma

Phase II Study of Ibrutinib in Combination With Rituximab-CHOP in Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma 54179060LYM2003 (Nick Name: IVORY Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	560 mg by mouth daily on day 1-21 per each cycle
DRUG	Rituximab	375 mg/m2 IV, day 1
DRUG	Cyclophosphamide	750 mg/m2 IV day 1
DRUG	Doxorubicin	50 mg/m2 IV day 1
DRUG	vincristine	1.4 mg/m2 IV on day 1
DRUG	Prednisolone	100mg per day on day 1-5

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-06-01
• Completion: 2020-10-01
• First posted: 2016-02-02
• Last updated: 2020-10-22

Locations

1 site across 1 country: South Korea