A Multicenter, Open-label, Phase 2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects with Relapsed or Refractory De Novo diffuse Large B-Cell Lymphoma (PCYC 1106)

Study Status

Open to Enrollment

Study Description

PCI-32765 is a type of drug called a “kinase inhibitor.” Kinsases are proteins inside cells that help cells live and grow. The specific kinase inhibited by this investigational drug is believed to help lymphoma cells live and grow. By inhibiting the activity of this specific kinase, it is possible the study drug may kill the lymphoma cells or stop them from growing.

The purpose of this study is to determine how well the study drug PCI-32765 works in treating people with diffuse large B-cell lymphoma (DLBCL) who have not responded well to previous treatment. This study is enrolling people with DLBCL who have already tried at least 1 previous anti-cancer therapy regimen.

All participants in this study will receive PCI-32765. There is no placebo. Participants will take 4 capsules a day by mouth and may continue to receive study drug as long as they are benefiting from the treatment and are not experiencing unacceptable side effects. There will be approximately 29 clinic visits in the study over about 2 years.

Disease Status and/or Stage

Relapsed or Refractory de Novo Diffuse Large B-cell Lymphoma (DLBCL)

Sponsor

Pharmacyclics

Key Eligibility

  • Men and women age 18 and older
  • De novo diffuse large B-cell lymphoma (DLBCL)
  • Relapsed or refractory disease (recurrence of disease after complete response, or progressive disease at completion of prior treatment regimen)
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Rebecca Elstrom, MD

Contact

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Contact Us

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

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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