Study of Ibrutinib and Rituximab in Treatment Na ve Follicular Lymphoma

  • STATUS
    Recruiting
  • End date
    Jan 30, 2025
  • participants needed
    440
  • sponsor
    Pharmacyclics LLC.
Updated on 16 June 2021
Investigator
Divya Chari
Primary Contact
Uniklinikum Salzburg (0.0 mi away) Contact
+220 other location
rituximab
measurable disease
follicular lymphoma
ibrutinib

Summary

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment nave subjects with follicular lymphoma.

Details
Condition Follicular Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, Treatment Naive Follicular Lymphoma
Treatment Rituximab, Ibrutinib, placebo to match ibrutinib
Clinical Study IdentifierNCT02947347
SponsorPharmacyclics LLC.
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease
Measurable disease
Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities
Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria
Adequate hematologic function within protocol-defined parameters
Adequate hepatic and renal function within protocol-defined parameters
ECOG performance status score of 0-2

Exclusion Criteria

Transformed lymphoma
Prior treatment for follicular lymphoma
Central nervous system lymphoma or leptomeningeal disease
Currently active, clinically significant cardiovascular disease
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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