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

  • STATUS
    Recruiting
  • End date
    Sep 22, 2022
  • participants needed
    362
  • sponsor
    Pharmacyclics LLC.
Updated on 22 November 2020
Investigator
Divya Chari
Primary Contact
Communal Institution O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Dept of Hematology with beds of Intensive Therapy (0.0 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
Treatment Ibrutinib, venetoclax, Placebo Oral tablet to match Venetoclax
Clinical Study IdentifierNCT03112174
SponsorPharmacyclics LLC.
Last Modified on22 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Mantle cell lymphoma or Non-Hodgkin's Lymphoma or Lymphoma?
Do you have any of these conditions: Mantle cell lymphoma or Lymphoma or Non-Hodgkin's Lymphoma?
Do you have any of these conditions: Lymphoma or Non-Hodgkin's Lymphoma or Mantle cell lymphoma?
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
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