SYMPATICO Study

Disease: R/R MCL 
Protocol: PCYC-1143

Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma 

Study Schema N=287

Sympatico Study

Primary Objective

  • To evaluate whether the combination of ibrutinib and venetoclax will result in prolongation of PFS compared to ibrutinib and placebo in subjects with relapsed or refractory MCL

Key Eligibility Criteria

Key Inclusion Criteria:

  • Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
  • At least 1 measurable site of disease on cross-sectional imaging (CT/PET)
  • At least 1, but no more than 5, prior treatment regimens for MCL
  • Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen
  • Subjects must have adequate fresh or paraffin embedded tissue

Key exclusion criteria

  • History or current evidence of central nervous system lymphoma
  • Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors
  • Prior treatment with venetoclax or other BCL2 inhibitors

 

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The information provided herein may contain references to ibrutinib or a use of ibrutinib which has not been approved by any regulatory agency. Providing this information should not be construed as recommending the use of ibrutinib for uses which may not have been approved by any regulatory agency. The safety and efficacy of the investigational use of ibrutinib has not been determined. There is no guarantee that the investigational uses listed will be filed with and/or approved for marketing by any regulatory agency. For additional information, you may visit www.clinicaltrials.gov. For products approved by any regulatory agency please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product for its approved indications.