PCI-32765 (Ibrutinib) in Patients with Newly Diagnosed non-Germinal Center B-Cell subtype of Diffuse Large B-Cell Lymphoma

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) that is potentially of non-Germinal Center B-Cell (non-GCB) origin.

The study is evaluating the addition of the experimental drug ibrutinib (also known as PCI-32765) to standard chemotherapy to see if it is effective in treating people with non-GCB DLBCL who have not been previously treated. 

Ibrutinib is an oral drug that inhibits the enzyme Bruton’s Tyrosine Kinase (BTK), decreasing the ability of lymphoma cells to grow and survive. R-CHOP (the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) is currently used as standard chemotherapy for newly diagnosed DLBCL. 

Study participants will be randomly assigned to one of two treatment arms: 

  •  Arm A: R-CHOP + Ibrutinib
  •  Arm B: R-CHOP + Placebo (a blank tablet that looks like ibrutinib but contains no medicine)

Study participants will receive 6 or 8 cycles of chemotherapy. Treatment cycles are 21 days. Participants will take ibrutinib/placebo once daily until the end of the chemotherapy cycles. 

Disease Status and/or Stage

Newly diagnosed

Sponsor

Janssen

Key Eligibility

  • Men and women age 18 and older
  • Non-GCB Diffuse Large B-cell Lymphoma (DLBCL)
  • No prior treatment for DLCBL
  • Detailed eligibility reviewed when you contact the study team

Healthy Volunteers

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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