Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 12/22/2018 |
| Start Date: | January 2017 |
| End Date: | January 2025 |
| Contact: | Silvie Aarts |
| Email: | medinfo@pcyc.com |
| Phone: | +1- 669- 224- 1860 |
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
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 naïve subjects with follicular lymphoma.
prolongation of progression-free survival (PFS) when compared with rituximab alone in
treatment naïve subjects with follicular lymphoma.
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
We found this trial at
44
sites
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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810 Hospital Drive
Blacksburg, Virginia 24060
Blacksburg, Virginia 24060
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
Newark, Delaware 19713
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