Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

Official Title

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

Keywords

Mantle-Cell Lymphoma PCYC MCL Non-Hodgkin's Lymphoma NHL ibrutinib venetoclax Pharmacyclics Lymphoma Lymphoma, Mantle-Cell

Eligibility

For people ages 18 years and up

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 Naïve 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-naïve 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

Locations

  • UCLA Department of Medicine-Hematology/Oncology accepting new patients
    Los Angeles California 90095 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT03112174
Phase
Phase 3
Study Type
Interventional
Last Updated