Last updated on August 2020

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-Hodgkin's Lymphoma | Mantle cell lymphoma | Lymphoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Relapsed/Refractory Arm

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

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

Treatment Nave Arm

Inclusion Criteria:

  • 65 years of age, or <65 years of age with a TP53 mutation
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
  • Adequate hematologic, hepatic, and renal function
  • Pathologically confirmed treatment-nave MCL
  • At least 1 measurable site of disease

Exclusion Criteria:

  • Blastoid variant of MCL
  • History or current evidence of CNS lymphoma
  • Concurrent enrollment in another therapeutic investigational study or prior therapy including ibrutinib or other BTK inhibitors
  • Prior treatment with venetoclax or other BCL2 inhibitors
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment
  • History of HIV or active HCV or HBV
  • Currently active, clinically significant cardiovascular disease; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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