info_resonate_2

Currently Recruiting Patients with Chronic Lymphocytic Leukemia/
Small Lymphocytic Lymphoma (PCYC-1115-CA) RESONATE™-2

A Randomized, Multicenter, Open-Label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) 
versus Chlorambucil in Patients 65 Years or Older with Treatment-naïve Chronic Lymphocytic Leukemia or 
Small Lymphocytic Lymphoma (RESONATE™-2)

CALL TOLL FREE
1-855-IBRUTINIB (1-855-427-8846), or e-mail medinfo@pcyc.com for more
information. Please visit ClinicalTrials.gov (NCT01722487 / NCT01724346)

PCYC 1116-CA: Open label extension study after PCYC-1115-CA (RESONATE™-2)

For patients who progress on the PCYC-1115-CA study, choice of second-line therapy can include:

  • Ibrutinib (for patients randomized to chlorambucil in the parent study who meet criteria)
  • Or other anticancer therapies at the discretion of the investigator

Information for RESONATE™-2 (PCYC-1115-CA)

Primary Objective: Progession Free Survival

Key Inclusion Criteria*

  • Age 65 years or older
  • Diagnosis of CLL or SLL that meets IWCLL 2008 criteria
  • Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment
  • ECOG performance status of 0-2
  • Measurable disease by computed tomography (CT)

Key Exclusion Criteria*

  • Known involvement of the central nervous system by leukemia or lymphoma
  • Any history or current evidence of Richter's transformation or prolymphocytic leukemia
  • Documentation of deletion 17p
  • Uncontrolled autoimmune hemolytic anemia (AHA) or idiopathic thrombocytopenic purpura (ITP)
  • Any previous treatment (chemotherapy, radiotherapy, and/or monoclonal antibodies) intended specifically to treat CLL/SLL
  • History of prior malignancy
  • Inability to swallow capsules or tablets
*Not a comprehensive list of inclusion or exclusion criteria