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A study of Ibrutinib in combination with Rituximab versus Placebo in combination with Rituximab in treatment of patients with Follicular Lymphoma
EU CTIS ID: 2023-507271-21-00
What this study is testing
To evaluate whether the addition of ibrutinib to rituximab will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- * 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.
You likely can't join if
- * Transformed lymphoma
- * Prior treatment for follicular lymphoma
- * Central nervous system lymphoma or leptomeningeal disease
- * Currently active, clinically significant cardiovascular disease
See the full eligibility 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.
- * Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator discretion should be applied.
- * Transformed lymphoma
- * Prior treatment for follicular lymphoma
- * Central nervous system lymphoma or leptomeningeal disease
- * Currently active, clinically significant cardiovascular disease
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Turkey
- New Zealand
- Israel
- Russian Federation
- Canada
- United Kingdom
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Turkey; New Zealand; Israel; Russian Federation and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.