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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 1, 2016

Status verified

Oct 2020

Primary completion

Jun 30, 2020

Completion

Oct 31, 2020

Study Design

Enrollment

24 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ibrutinib in combination with r-CHOP
  Ibrutinib560 mg daily on day 1-21 per each cycle ,Rituximab375 mg/m2, Cyclophosphamide750 mg/m2, doxorubicin 50 mg/m2, vincristine1.4 mg/m2 on day 1; Prednisolone 100mg per day on day 1-5 ,cycle length: 21 days ,Six cycles of treatment

Primary Outcome Measure

complete response rate [ Time Frame: From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48 months ]