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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    362
  • sponsor
    Pharmacyclics LLC.
Updated on 1 August 2021
Investigator
Alina Smith
Primary Contact
St.Vincent's Hospital (5.0 mi away) Contact
+179 other location
venetoclax
TP53
mantle cell lymphoma
renal function tests
ibrutinib
cyclin d1

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.

Details
Condition Lymphoma, Mantle cell lymphoma, Non-Hodgkin's Lymphoma
Treatment Ibrutinib, venetoclax, Placebo Oral tablet to match Venetoclax
Clinical Study IdentifierNCT03112174
SponsorPharmacyclics LLC.
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologically confirmed treatment-naive MCL (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)
Men and women 18 years of age with a TP53 mutation
Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
Adequate hematologic, hepatic, and renal function
Must have adequate fresh or paraffin-embedded tissue
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
Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug
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
Clinically significant infection requiring IV systemic treatment that was completed <=14 days before the first dose of study drug
Any uncontrolled active systemic infection
Known bleeding disorders (eg, von Willebrand's disease or hemophilia)
Major surgery within 4 weeks of the first dose of study drug
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the participant's safety or put the study outcomes at undue risk
Unable to swallow capsules or tablets, or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
Treatment with any of the following within 7 days prior to the first dose of study drug: Moderate or strong cytochrome P450 3A (CYP3A) inhibitors or moderate or strong CYP3A inducers
Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects with known risk factors (as defined by high tumor burden and/or diminished renal function, as detailed in "Study Design" section above) for TLS
Chronic liver disease with hepatic impairment Child-Pugh class B or C
Unwilling or unable to participate in all required study evaluations and procedures
Known hypersensitivity to the active ingredient or other components of one or more study drugs
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